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

Astellas

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: ASP0777; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01406145

0777-CL-0030

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

ASP0777 low dose

Experimental group

Description:

ASP0777 low dose for 6 weeks

Treatment:

Drug: ASP0777

ASP0777 low dose, then high dose

Experimental group

Description:

ASP0777 low dose for 1 week and ASP0777 high dose for 5 weeks

Treatment:

Drug: ASP0777

ASP0777 high dose

Experimental group

Description:

ASP0777 high dose for 6 weeks

Treatment:

Drug: ASP0777

Placebo

Placebo Comparator group

Description:

Placebo for 6 weeks

Treatment:

Drug: Placebo