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ELND005 in Patients With Mild to Moderate Alzheimer's Disease

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:
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited

Study Type Interventional
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
Enrollment 353
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Hide Arm/Group Description oral administration for 78 weeks oral administration for 78 weeks oral administration for 78 weeks oral administration for 78 weeks
Period Title: Overall Study
Started 83 [1] 88 [2] 89 [3] 91 [4]
Completed 53 52 15 19
Not Completed 30 36 74 72
Reason Not Completed
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
[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41 patients withdrawn per interim safety review (sponsors decision); excluded in efficacy analysis.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42 patients withdrawn per interim safety review (sponsors decision); excluded in efficacy analysis.
Arm/Group Title Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID Total
Hide Arm/Group Description oral administration for 78 weeks oral administration for 78 weeks oral administration for 78 weeks oral administration for 78 weeks Total of all reporting groups
Overall Number of Baseline Participants 83 88 89 91 351
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 88 participants 89 participants 91 participants 351 participants
73.4  (7.83) 73.4  (7.26) 73.4  (7.56) 72.2  (8.20) 73.1  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 88 participants 89 participants 91 participants 351 participants
Female
47
  56.6%
51
  58.0%
48
  53.9%
51
  56.0%
197
  56.1%
Male
36
  43.4%
37
  42.0%
41
  46.1%
40
  44.0%
154
  43.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 83 participants 88 participants 89 participants 91 participants 351 participants
United States 68 75 71 75 289
Canada 15 13 18 16 62
1.Primary Outcome
Title Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Hide Arm/Group Description:
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
Overall Number of Participants Analyzed 82 84 0 0
Mean (Standard Error)
Unit of Measure: Scores on a Scale
-0.383  (0.075) -0.350  (0.074)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo BID, ELND005 250 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.14 to 0.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
2.Primary Outcome
Title Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Hide Arm/Group Description:
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
Overall Number of Participants Analyzed 47 49 0 0
Mean (Standard Error)
Unit of Measure: Scores on a Scale
-0.369  (0.093) -0.222  (0.095)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo BID, ELND005 250 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.06 to 0.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Hide Arm/Group Description:
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
Overall Number of Participants Analyzed 82 84 0 0
Mean (Standard Error)
Unit of Measure: Scores on a Scale
-9.467  (1.641) -10.861  (1.604)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo BID, ELND005 250 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.39
Confidence Interval (2-Sided) 95%
-5.41 to 2.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.03
Estimation Comments [Not Specified]
4.Primary Outcome
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Hide Arm/Group Description:
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
Overall Number of Participants Analyzed 47 49 0 0
Mean (Standard Error)
Unit of Measure: Scores on a Scale
-9.635  (1.779) -8.987  (1.760)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo BID, ELND005 250 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
-3.73 to 5.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.20
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Alzheimer‘s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Hide Arm/Group Description:
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
Overall Number of Participants Analyzed 82 84 0 0
Mean (Standard Error)
Unit of Measure: Scores on a Scale
-8.239  (1.531) -10.796  (1.540)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo BID, ELND005 250 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.56
Confidence Interval (2-Sided) 95%
-6.33 to 1.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.90
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Hide Arm/Group Description:
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
Overall Number of Participants Analyzed 82 84 0 0
Mean (Standard Error)
Unit of Measure: Scores on a Scale
-2.742  (0.363) -2.452  (0.357)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo BID, ELND005 250 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
-0.63 to 1.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.47
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Hide Arm/Group Description:
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
oral administration for 78 weeks
Overall Number of Participants Analyzed 82 84 0 0
Mean (Standard Error)
Unit of Measure: Scores on a Scale
-6.132  (1.851) -5.116  (1.814)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo BID, ELND005 250 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
-3.43 to 5.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.24
Estimation Comments [Not Specified]
Time Frame Reported adverse events include events starting at or after Screening to Week 84
Adverse Event Reporting Description For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
 
Arm/Group Title Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Hide Arm/Group Description oral administration for 78 weeks oral administration for 78 weeks oral administration for 78 weeks oral administration for 78 weeks
All-Cause Mortality
Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/83 (13.25%)   19/88 (21.59%)   20/89 (22.47%)   21/91 (23.08%) 
Blood and lymphatic system disorders         
Haemorrhagic Anaemia  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Cardiac disorders         
Angina Unstable  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  0/91 (0.00%) 
Atrial Fribrillation  1  1/83 (1.20%)  1/88 (1.14%)  1/89 (1.12%)  1/91 (1.10%) 
Atrial Futter  1  1/83 (1.20%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Cardiac Arrest  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Cardiac Failure Congestive  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  2/91 (2.20%) 
Coronary Artery Occlusion  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Myocardial Infarction  1  1/83 (1.20%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Supraventricular Tachycardia  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Eye disorders         
Glaucoma  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  0/91 (0.00%) 
Retinal Vein Occlusion  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  0/91 (0.00%) 
Vitreous Haemorrhage  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  0/91 (0.00%) 
Gastrointestinal disorders         
Gastric Ulcer Haemorrhage  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  0/91 (0.00%) 
Gastritis  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Gastritis Hemorrhagic  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Hemorrhoidal hemorrhage  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Pancreatitis  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  0/91 (0.00%) 
Small Intestinal Obstruction  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
General disorders         
Hypothermia  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  0/91 (0.00%) 
Sudden Death  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  1/91 (1.10%) 
Hepatobiliary disorders         
Cholecystitis  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Infections and infestations         
Arthritis Bacterial  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Bacterial Sepsis  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Kidney Infection  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Pneumonia  1  0/83 (0.00%)  0/88 (0.00%)  2/89 (2.25%)  3/91 (3.30%) 
Pneumonia Bacterial  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Staphylococcal Infection  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Urinary Tract Infection  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  3/91 (3.30%) 
Urosepsis  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Viral Infection  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Injury, poisoning and procedural complications         
Accidental Overdose  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Compression Fracture  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Contusion  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Fall  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  1/91 (1.10%) 
Hip Fracture  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Jaw Fracture  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Laceration  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Multiple Fractures  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Post Procedural Haematoma  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Postoperative Ileus  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Subdural Hematoma  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  0/91 (0.00%) 
Investigations         
Electrocardiogram Change  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Hepatic Enzyme Increased  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Lipase Increased  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Metabolism and nutrition disorders         
Dehydration  1  2/83 (2.41%)  1/88 (1.14%)  2/89 (2.25%)  2/91 (2.20%) 
Failure to Thrive  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Hyperglycemia  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Musculoskeletal and connective tissue disorders         
Mobility Decreased  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal Cell Carcinoma  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Breast Cancer  1  0/83 (0.00%)  3/88 (3.41%)  0/89 (0.00%)  0/91 (0.00%) 
Breast Cancer In Situ  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Colon Cancer  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Colorectal Cancer  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Renal Cell Carcinoma  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  2/91 (2.20%) 
Squamous Cell Carcinoma  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Squamous Cell Carcinoma of Skin  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Nervous system disorders         
Carotid Artery Occlusion  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  0/91 (0.00%) 
Cerebral Hemorrhage  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Cerebrovascular Accident  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  1/91 (1.10%) 
Dementia Alzheimer‘s Type  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Dizziness  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Encephalopathy  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Haemorrhagic Stroke  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  0/91 (0.00%) 
Ischaemic Cerebral Infarction  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Syncope  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  1/91 (1.10%) 
Transient Ischaemic Attack  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Psychiatric disorders         
Acute Psychosis  1  0/83 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/91 (1.10%) 
Agitation  1  0/83 (0.00%)  1/88 (1.14%)  1/89 (1.12%)  0/91 (0.00%) 
Confusional State  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Delirium  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Mental Status Changes  1  1/83 (1.20%)  0/88 (0.00%)  0/89 (0.00%)  0/91 (0.00%) 
Psychotic Disorder  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  1/91 (1.10%) 
Renal and urinary disorders         
Renal Failure Acute  1  0/83 (0.00%)  0/88 (0.00%)  2/89 (2.25%)  0/91 (0.00%) 
Urinary Retention  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/91 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pleural Effusion  1  0/83 (0.00%)  0/88 (0.00%)  2/89 (2.25%)  0/91 (0.00%) 
Pneumonia Aspiration  1  0/83 (0.00%)  0/88 (0.00%)  2/89 (2.25%)  0/91 (0.00%) 
Pneumothorax  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Pulmonary Embolism  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  1/91 (1.10%) 
Respiratory Failure  1  0/83 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  1/91 (1.10%) 
Vascular disorders         
Aortic Thrombosis  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Deep Vein Thrombosis  1  0/83 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/91 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo BID ELND005 250 mg BID ELND005 1000 mg BID ELND005 2000 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   48/83 (57.83%)   46/88 (52.27%)   45/89 (50.56%)   57/91 (62.64%) 
Gastrointestinal disorders         
Diarrhoea  1  6/83 (7.23%)  9/88 (10.23%)  8/89 (8.99%)  12/91 (13.19%) 
Nausea  1  4/83 (4.82%)  8/88 (9.09%)  3/89 (3.37%)  14/91 (15.38%) 
Vomiting  1  3/83 (3.61%)  5/88 (5.68%)  3/89 (3.37%)  8/91 (8.79%) 
General disorders         
Fatigue  1  4/83 (4.82%)  6/88 (6.82%)  6/89 (6.74%)  7/91 (7.69%) 
Infections and infestations         
Urinary Tract Infection  1  7/83 (8.43%)  12/88 (13.64%)  4/89 (4.49%)  11/91 (12.09%) 
Upper Respiratory Tract Infection  1  5/83 (6.02%)  9/88 (10.23%)  3/89 (3.37%)  3/91 (3.30%) 
Injury, poisoning and procedural complications         
Fall  1  5/83 (6.02%)  11/88 (12.50%)  10/89 (11.24%)  14/91 (15.38%) 
Nervous system disorders         
Dizziness  1  7/83 (8.43%)  4/88 (4.55%)  6/89 (6.74%)  11/91 (12.09%) 
Headache  1  12/83 (14.46%)  4/88 (4.55%)  11/89 (12.36%)  8/91 (8.79%) 
Psychiatric disorders         
Agitation  1  5/83 (6.02%)  4/88 (4.55%)  9/89 (10.11%)  6/91 (6.59%) 
Confusional State  1  3/83 (3.61%)  7/88 (7.95%)  4/89 (4.49%)  4/91 (4.40%) 
Depression  1  4/83 (4.82%)  10/88 (11.36%)  4/89 (4.49%)  12/91 (13.19%) 
Insomnia  1  5/83 (6.02%)  3/88 (3.41%)  2/89 (2.25%)  8/91 (8.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
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.
Investigator may publish after release of multi-center study publication, or 18 months after database lock of overall study. Sponsor has 60 days to review any proposed publication and request removal of Sponsor’s confidential information. Sponsor may request an additional 90 days if filing a patent.
Results Point of Contact
Name/Title: Aleksandra pastrak, MD, PhD, Vice President, Clinical Development
Organization: Transition Therapeutics Ireland Limited
Phone: +1 416 263 1227
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