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

• Status: Completed
• Trial end date: 2011-11-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Donepezil

Criteria

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