ELND005 in Patients With Mild to Moderate Alzheimer's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00568776 |
Recruitment Status
:
Completed
First Posted
: December 6, 2007
Results First Posted
: March 29, 2012
Last Update Posted
: May 16, 2016
|
Sponsor:
Transition Therapeutics Ireland Limited
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition: |
Alzheimer Disease |
Interventions: |
Drug: Placebo Control Drug: ELND005 |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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No text entered. |
Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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No text entered. |
Reporting Groups
Description | |
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Placebo BID | oral administration for 78 weeks |
ELND005 250 mg BID | oral administration for 78 weeks |
ELND005 1000 mg BID | oral administration for 78 weeks |
ELND005 2000 mg BID | oral administration for 78 weeks |
Participant Flow: Overall Study
Placebo BID | ELND005 250 mg BID | ELND005 1000 mg BID | ELND005 2000 mg BID | |
---|---|---|---|---|
STARTED | 83 [1] | 88 [2] | 89 [3] | 91 [4] |
COMPLETED | 53 | 52 | 15 | 19 |
NOT COMPLETED | 30 | 36 | 74 | 72 |
Adverse Event | 8 | 8 | 10 | 8 |
Death | 0 | 1 | 4 | 3 |
Physician Decision | 0 | 2 | 0 | 0 |
Lack of Efficacy | 2 | 2 | 2 | 4 |
Lost to Follow-up | 1 | 1 | 1 | 1 |
Protocol Violation | 1 | 0 | 1 | 1 |
Withdrawal by Subject | 13 | 15 | 13 | 7 |
Loss of Caregiver | 0 | 2 | 1 | 2 |
Sponsor Decision | 2 | 2 | 41 | 42 |
Miscellaeneous | 3 | 3 | 1 | 4 |
[1] | One randomized patient withdrew consent and did not receive placebo |
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[2] | One randomized patient withdrew consent and did not receive ELND005 250 mg BID |
[3] | 41 patients withdrawn per interim safety review (sponsors decision); excluded in efficacy analysis. |
[4] | 42 patients withdrawn per interim safety review (sponsors decision); excluded in efficacy analysis. |

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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No text entered. |
Reporting Groups
Description | |
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Placebo BID | oral administration for 78 weeks |
ELND005 250 mg BID | oral administration for 78 weeks |
ELND005 1000 mg BID | oral administration for 78 weeks |
ELND005 2000 mg BID | oral administration for 78 weeks |
Total | Total of all reporting groups |
Baseline Measures
Placebo BID | ELND005 250 mg BID | ELND005 1000 mg BID | ELND005 2000 mg BID | Total | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Overall Participants Analyzed [Units: Participants] |
83 | 88 | 89 | 91 | 351 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Age [Units: Years] Mean (Standard Deviation) |
73.4 (7.83) | 73.4 (7.26) | 73.4 (7.56) | 72.2 (8.20) | 73.1 (7.7) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Gender [Units: Patients] |
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Female | 47 | 51 | 48 | 51 | 197 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Male | 36 | 37 | 41 | 40 | 154 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Region of Enrollment [Units: Patients] |
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United States | 68 | 75 | 71 | 75 | 289 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Canada | 15 | 13 | 18 | 16 | 62 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

1. Primary: | Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] |
Measure Type | Primary |
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Measure Title | Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS) |
Measure Description | The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment. |
Time Frame | Baseline and 78 weeks |
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit. |
Reporting Groups
Description | |
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Placebo BID | oral administration for 78 weeks |
ELND005 250 mg BID | oral administration for 78 weeks |
ELND005 1000 mg BID | oral administration for 78 weeks |
ELND005 2000 mg BID | oral administration for 78 weeks |
Measured Values
Placebo BID | ELND005 250 mg BID | ELND005 1000 mg BID | ELND005 2000 mg BID | |
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Participants Analyzed [Units: Participants] |
82 | 84 | 0 | 0 |
Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS) [Units: Scores on a Scale] Mean (Standard Error) |
-0.383 (0.075) | -0.350 (0.074) |
Statistical Analysis 1 for Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)
Groups [1] | Placebo BID vs. ELND005 250 mg BID |
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Statistical Test Type [2] | Superiority or Other |
Statistical Method [3] | Mixed Models Analysis |
P Value [4] | 0.71 |
Mean Difference (Final Values) [5] | 0.03 |
95% Confidence Interval | -0.14 to 0.21 |
Standard Error of the mean | (0.09) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |
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[3] | Other relevant method information, such as adjustments or degrees of freedom: |
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[4] | Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: |
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[5] | Other relevant estimation information: |
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2. Primary: | Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS) [ Time Frame: Baseline and 78 weeks ] |
Measure Type | Primary |
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Measure Title | Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS) |
Measure Description | The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment. |
Time Frame | Baseline and 78 weeks |
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria. |
Reporting Groups
Description | |
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Placebo BID | oral administration for 78 weeks |
ELND005 250 mg BID | oral administration for 78 weeks |
ELND005 1000 mg BID | oral administration for 78 weeks |
ELND005 2000 mg BID | oral administration for 78 weeks |
Measured Values
Placebo BID | ELND005 250 mg BID | ELND005 1000 mg BID | ELND005 2000 mg BID | |
---|---|---|---|---|
Participants Analyzed [Units: Participants] |
47 | 49 | 0 | 0 |
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS) [Units: Scores on a Scale] Mean (Standard Error) |
-0.369 (0.093) | -0.222 (0.095) |
Statistical Analysis 1 for Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)
Groups [1] | Placebo BID vs. ELND005 250 mg BID |
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Statistical Test Type [2] | Superiority or Other |
Statistical Method [3] | Mixed Models Analysis |
P Value [4] | 0.17 |
Mean Difference (Final Values) [5] | 0.15 |
95% Confidence Interval | -0.06 to 0.36 |
Standard Error of the mean | (0.11) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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No text entered. | |
[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |
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[3] | Other relevant method information, such as adjustments or degrees of freedom: |
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3. Primary: | Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] |
Measure Type | Primary |
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Measure Title | Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS) |
Measure Description | The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment. |
Time Frame | Baseline and 78 weeks |
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit. |
Reporting Groups
Description | |
---|---|
Placebo BID | oral administration for 78 weeks |
ELND005 250 mg BID | oral administration for 78 weeks |
ELND005 1000 mg BID | oral administration for 78 weeks |
ELND005 2000 mg BID | oral administration for 78 weeks |
Measured Values
Placebo BID | ELND005 250 mg BID | ELND005 1000 mg BID | ELND005 2000 mg BID | |
---|---|---|---|---|
Participants Analyzed [Units: Participants] |
82 | 84 | 0 | 0 |
Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS) [Units: Scores on a Scale] Mean (Standard Error) |
-9.467 (1.641) | -10.861 (1.604) |
Statistical Analysis 1 for Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)
Groups [1] | Placebo BID vs. ELND005 250 mg BID |
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Statistical Test Type [2] | Superiority or Other |
Statistical Method [3] | Mixed Models Analysis |
P Value [4] | 0.49 |
Mean Difference (Final Values) [5] | -1.39 |
95% Confidence Interval | -5.41 to 2.62 |
Standard Error of the mean | (2.03) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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4. Primary: | Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS) [ Time Frame: Baseline and 78 weeks ] |
Measure Type | Primary |
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Measure Title | Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS) |
Measure Description | The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment. |
Time Frame | Baseline and 78 weeks |
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria. |
Reporting Groups
Description | |
---|---|
Placebo BID | oral administration for 78 weeks |
ELND005 250 mg BID | oral administration for 78 weeks |
ELND005 1000 mg BID | oral administration for 78 weeks |
ELND005 2000 mg BID | oral administration for 78 weeks |
Measured Values
Placebo BID | ELND005 250 mg BID | ELND005 1000 mg BID | ELND005 2000 mg BID | |
---|---|---|---|---|
Participants Analyzed [Units: Participants] |
47 | 49 | 0 | 0 |
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS) [Units: Scores on a Scale] Mean (Standard Error) |
-9.635 (1.779) | -8.987 (1.760) |
Statistical Analysis 1 for Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)
Groups [1] | Placebo BID vs. ELND005 250 mg BID |
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Statistical Test Type [2] | Superiority or Other |
Statistical Method [3] | Mixed Models Analysis |
P Value [4] | 0.77 |
Mean Difference (Final Values) [5] | 0.65 |
95% Confidence Interval | -3.73 to 5.03 |
Standard Error of the mean | (2.20) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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5. Secondary: | Change in Alzheimer‘s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] |
Measure Type | Secondary |
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Measure Title | Change in Alzheimer‘s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS) |
Measure Description | The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment. |
Time Frame | Baseline and 78 weeks |
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit. |
Reporting Groups
Description | |
---|---|
Placebo BID | oral administration for 78 weeks |
ELND005 250 mg BID | oral administration for 78 weeks |
ELND005 1000 mg BID | oral administration for 78 weeks |
ELND005 2000 mg BID | oral administration for 78 weeks |
Measured Values
Placebo BID | ELND005 250 mg BID | ELND005 1000 mg BID | ELND005 2000 mg BID | |
---|---|---|---|---|
Participants Analyzed [Units: Participants] |
82 | 84 | 0 | 0 |
Change in Alzheimer‘s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS) [Units: Scores on a Scale] Mean (Standard Error) |
-8.239 (1.531) | -10.796 (1.540) |
Statistical Analysis 1 for Change in Alzheimer‘s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Groups [1] | Placebo BID vs. ELND005 250 mg BID |
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Statistical Test Type [2] | Superiority or Other |
Statistical Method [3] | Mixed Models Analysis |
P Value [4] | 0.18 |
Mean Difference (Final Values) [5] | -2.56 |
95% Confidence Interval | -6.33 to 1.22 |
Standard Error of the mean | (1.90) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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6. Secondary: | Change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] |
Measure Type | Secondary |
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Measure Title | Change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS) |
Measure Description | The CDR-SB consists of 6 items; 3 measuring cognitive ability and 3 measuring functional ability. The score for each of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment. |
Time Frame | Baseline and 78 weeks |
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit. |
Reporting Groups
Description | |
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Placebo BID | oral administration for 78 weeks |
ELND005 250 mg BID | oral administration for 78 weeks |
ELND005 1000 mg BID | oral administration for 78 weeks |
ELND005 2000 mg BID | oral administration for 78 weeks |
Measured Values
Placebo BID | ELND005 250 mg BID | ELND005 1000 mg BID | ELND005 2000 mg BID | |
---|---|---|---|---|
Participants Analyzed [Units: Participants] |
82 | 84 | 0 | 0 |
Change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS) [Units: Scores on a Scale] Mean (Standard Error) |
-2.742 (0.363) | -2.452 (0.357) |
Statistical Analysis 1 for Change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Groups [1] | Placebo BID vs. ELND005 250 mg BID |
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Statistical Test Type [2] | Superiority or Other |
Statistical Method [3] | Mixed Models Analysis |
P Value [4] | 0.54 |
Mean Difference (Final Values) [5] | 0.29 |
95% Confidence Interval | -0.63 to 1.21 |
Standard Error of the mean | (0.47) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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[4] | Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: |
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7. Secondary: | Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] |
Measure Type | Secondary |
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Measure Title | Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS) |
Measure Description | The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 to 12; hence the total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment. |
Time Frame | Baseline and 78 weeks |
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit. |
Reporting Groups
Description | |
---|---|
Placebo BID | oral administration for 78 weeks |
ELND005 250 mg BID | oral administration for 78 weeks |
ELND005 1000 mg BID | oral administration for 78 weeks |
ELND005 2000 mg BID | oral administration for 78 weeks |
Measured Values
Placebo BID | ELND005 250 mg BID | ELND005 1000 mg BID | ELND005 2000 mg BID | |
---|---|---|---|---|
Participants Analyzed [Units: Participants] |
82 | 84 | 0 | 0 |
Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS) [Units: Scores on a Scale] Mean (Standard Error) |
-6.132 (1.851) | -5.116 (1.814) |
Statistical Analysis 1 for Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Groups [1] | Placebo BID vs. ELND005 250 mg BID |
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Statistical Test Type [2] | Superiority or Other |
Statistical Method [3] | Mixed Models Analysis |
P Value [4] | 0.65 |
Mean Difference (Final Values) [5] | 1.02 |
95% Confidence Interval | -3.43 to 5.46 |
Standard Error of the mean | (2.24) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |
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[3] | Other relevant method information, such as adjustments or degrees of freedom: |
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[4] | Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: |
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[5] | Other relevant estimation information: |
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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The two high dose groups of ELND005 were discontinued before study end, so the efficacy analysis was based only on placebo and ELND005 250 mg bid groups. |

Certain Agreements:
Results Point of Contact:
Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Results Point of Contact:
Name/Title: Aleksandra pastrak, MD, PhD, Vice President, Clinical Development
Organization: Transition Therapeutics Ireland Limited
phone: +1 416 263 1227
e-mail: apastrak@transitiontherapeutics.com
Organization: Transition Therapeutics Ireland Limited
phone: +1 416 263 1227
e-mail: apastrak@transitiontherapeutics.com
Responsible Party: | Transition Therapeutics Ireland Limited |
ClinicalTrials.gov Identifier: | NCT00568776 History of Changes |
Other Study ID Numbers: |
ELND005-AD201 |
First Submitted: | December 4, 2007 |
First Posted: | December 6, 2007 |
Results First Submitted: | September 27, 2011 |
Results First Posted: | March 29, 2012 |
Last Update Posted: | May 16, 2016 |