A Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease (AD) Taking a Stable Dose of Donepezil
NCT ID: NCT01406145
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2011-06-16
2011-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ASP0777 low dose
ASP0777 low dose for 6 weeks
ASP0777
oral tablet
ASP0777 low dose, then high dose
ASP0777 low dose for 1 week and ASP0777 high dose for 5 weeks
ASP0777
oral tablet
ASP0777 high dose
ASP0777 high dose for 6 weeks
ASP0777
oral tablet
Placebo
Placebo for 6 weeks
Placebo
oral tablet
Interventions
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ASP0777
oral tablet
Placebo
oral tablet
Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Pacific Research Network, Inc.
San Diego, California, United States
MD Clinical
Hallandale, Florida, United States
Countries
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Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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0777-CL-0030
Identifier Type: -
Identifier Source: org_study_id
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