ELND005 in Patients With Mild to Moderate Alzheimer's Disease

This study has been completed.

Sponsor:

Collaborator:

Transition Therapeutics

Information provided by (Responsible Party):

Transition Therapeutics Ireland Limited

ClinicalTrials.gov Identifier:

NCT00568776

First received: December 4, 2007

Last updated: December 1, 2014

Last verified: December 2014

History of Changes

Results First Received: September 27, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Alzheimer Disease
Interventions:	Drug: Placebo Control Drug: ELND005

Participant Flow

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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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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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
[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[3]	41 patients withdrawn per interim safety review (sponsors decision); excluded in efficacy analysis.
[4]	42 patients withdrawn per interim safety review (sponsors decision); excluded in efficacy analysis.

Baseline Characteristics

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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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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
Total	Total of all reporting groups

Baseline Measures

	Placebo BID	ELND005 250 mg BID	ELND005 1000 mg BID	ELND005 2000 mg BID	Total
Number of Participants [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]
Female	47	51	48	51	197
Male	36	37	41	40	154
Region of Enrollment [units: patients]
United States	68	75	71	75	289
Canada	15	13	18	16	62

Outcome Measures

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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.

More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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: Executive Vice President of Global Development and Chief Medical Officer
Organization: Elan Pharmaceuticals, Inc.
phone: 650 877 0900

No publications provided

Responsible Party:	Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier:	NCT00568776 History of Changes
Other Study ID Numbers:	ELND005-AD201
Study First Received:	December 4, 2007
Results First Received:	September 27, 2011
Last Updated:	December 1, 2014
Health Authority:	United States: Food and Drug Administration

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