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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406145
• Other study ID #: 0777-CL-0030
• Status: Completed
• Phase: Phase 1
• Start date: June 16, 2011
• Est. completion date: November 4, 2011

Study information

• Verified date: January 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 4, 2011
• Est. primary completion date: November 4, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ASP0777
oral tablet
• Placebo
oral tablet

Locations

Country	Name	City	State
United States	MD Clinical	Hallandale Beach	Florida
United States	Pacific Research Network, Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of subjects with adverse events		Up to 56 Days
Secondary	Pharmacokinetic assessment of AUC, maximum concentration (Cmax), minimum concentration (Cmin) and time to maximum concentration (tmax) through analysis of blood samples		Up to 56 Days

External Links

•   Link to results on the Astellas Clinical Study Results website