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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01406145

Run by

Astellas Pharma Inc

People needed

60

Starts

2011-06-16

Expected to finish

2011-11-04

Last updated by the study team

2024-10-30

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pacific Research Network, Inc. — San Diego, California, United States
• MD Clinical — Hallandale, Florida, United States

Full record on ClinicalTrials.gov

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