Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)

Study Overview
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Brief Summary
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The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.

Official Title
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A 3-Month, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study Of 3 Doses Of Lecozotan (SRA-333) SR In Outpatients With Mild To Moderate Alzheimer's Disease With Donepezil As Active Control.

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: lecozotan SR
* Drug: Donepezil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of probable AD according to the NINCDS-ADRDA criteria. Able to give informed consent. Patient' s caregiver must consent to participate in the study. Exclusion Criteria: Use of medications for cognitive enhancement within 3 months of baseline. Significant neurologic disease other than AD that may affect cognition.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: lecozotan SR<br>* evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks. Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil.<br>|
| Experimental: B<br> | Drug: lecozotan SR<br>* evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks. Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil.<br>|
| Experimental: C<br> | Drug: lecozotan SR<br>* evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks. Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil.<br>|
| Active Comparator: D<br> | Drug: Donepezil<br>* 10 mg donepezil QD dosed up to 40 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score. |  | weeks 12, 14, 26 and 40. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures. |  | weeks 12, 14, 26 and 40. |