A Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease (AD) Taking a Stable Dose of Donepezil

Study Overview
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Brief Summary
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This study is intended to determine the safety and tolerability of ASP0777 in subjects with Alzheimer's Disease (AD) taking a stable dose of donepezil.

Official Title
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A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Sequential Dose Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease on Donepezil

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: ASP0777
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a Mini-Mental Status Exam score of 18-26 Subject has a diagnosis of probable Alzheimer's Disease Subject has used donepezil for at least 3 months and has been on a stable dose for at least 6 weeks prior to screening Subject has a reliable adult who is residing with him/her during the outpatient portion of the study Subject is medically stable Subject has adequate cognitive, hearing, vision, and language skills Subject is able to ingest oral tablets Exclusion Criteria: Subject has received any investigational product in another clinical study or post-marketing clinical study within past 3 months Subject has any clinically significant abnormal laboratory tests Subject is a female who is pregnant, lactating or of childbearing potential who refuses to use a form of contraception during the study Subject has a history of a drug allergy or intolerance to memantine or a related compound Subject is currently using anti-dementia drugs (except for donepezil) or has used any such drugs within the last 4 weeks Subject has a score of 2 on item 16 of Cornell Scale for Depression in Dementia (CSDD) or has an overall CSDD score > 10 Subject is using off-label medicines, non-medicinal compounds, or dietary aids/food supplements to improve cognition that have not been at a stable dose for at least 4 weeks prior to Screening and/or are anticipated to change dosing regimen during the study Subject has a history of drug or alcohol abuse within the past 12 months or subject consumes > 1 drink of alcohol daily, or is unable to refrain from alcohol during the study Subject is a current smoker or recently quit smoking (within the past 12 months) Subject has a clinically significant medical condition that is unstable or is likely to become unstable during the course of the study Subject has history of seizures, other than febrile seizures during infancy Subject has history of repeated falls within past 6 months Subject has a major psychiatric illness or has received treatment for symptoms of a major psychiatric illness within past 1 year. Mild psychiatric disorders are allowable

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: ASP0777 low dose<br>ASP0777 low dose for 6 weeks | Drug: ASP0777<br>* oral tablet<br>|
| Experimental: ASP0777 low dose, then high dose<br>ASP0777 low dose for 1 week and ASP0777 high dose for 5 weeks | Drug: ASP0777<br>* oral tablet<br>|
| Experimental: ASP0777 high dose<br>ASP0777 high dose for 6 weeks | Drug: ASP0777<br>* oral tablet<br>|
| Placebo Comparator: Placebo<br>Placebo for 6 weeks | Drug: Placebo<br>* oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of subjects with adverse events |  | Up to 56 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic assessment of AUC, maximum concentration (Cmax), minimum concentration (Cmin) and time to maximum concentration (tmax) through analysis of blood samples |  | Up to 56 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP0777, Alzheimer's Disease