Clinical trial NCT01406145: A Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease (AD) Taking a Stable Dose of Donepezil
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: ASP0777
Alzheimer's Disease
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Number and percentage of subjects with adverse events
timeFrame: Up to 56 Days
Secondary outcomes:
measure: Pharmacokinetic assessment of AUC, maximum concentration (Cmax), minimum concentration (Cmin) and time to maximum concentration (tmax) through analysis of blood samples
timeFrame: Up to 56 Days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pacific Research Network, Inc.
state: California
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References: