ELND005 in Patients With Mild to Moderate Alzheimer's Disease

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

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.
No text entered.

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
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]
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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

7.  Secondary:

Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)   [ Time Frame: Baseline and 78 weeks ]

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.