CompletedPhase 1

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

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

Lead sponsor

Astellas Pharma Inc

Asset

ASP0777

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•AD symptomatic therapy: stable ≥6 weeks

Primary endpoint

•Number and percentage of subjects with adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID0777-CL-0030

NCT IDNCT01406145

Timeline

Milestones

Study start2011-06-16actual

Study first posted2011-08-01estimated

Primary completion2011-11-04actual

Study completion2011-11-04actual

Last update posted2024-10-30actual

Assets

Drug assets

ASP0777

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number and percentage of subjects with adverse events

Time frame:Up to 56 Days

threshold achievement, event

Secondary/protocol endpoint

Pharmacokinetic assessment of AUC, maximum concentration (Cmax), minimum concentration (Cmin) and time to maximum concentration (tmax) through analysis of blood samples

Time frame:Up to 56 Days

time to event, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.