Status:
COMPLETED
A Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease (AD) Taking a Stable Dose of Donepezil
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01406145
Start Date
June 16 2011
End Date
November 4 2011
Last Update
October 30 2024
Active Locations (2)
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1
Pacific Research Network, Inc.
San Diego, California, United States, 92103
2
MD Clinical
Hallandale, Florida, United States, 33009