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
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2011
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 16, 2011
CompletedFirst Submitted
Initial submission to the registry
July 6, 2011
CompletedFirst Posted
Study publicly available on registry
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2011
CompletedOctober 30, 2024
October 1, 2024
5 months
July 6, 2011
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and percentage of subjects with adverse events
Up to 56 Days
Secondary Outcomes (1)
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
Study Arms (4)
ASP0777 low dose
EXPERIMENTALASP0777 low dose for 6 weeks
ASP0777 low dose, then high dose
EXPERIMENTALASP0777 low dose for 1 week and ASP0777 high dose for 5 weeks
ASP0777 high dose
EXPERIMENTALASP0777 high dose for 6 weeks
Placebo
PLACEBO COMPARATORPlacebo for 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pacific Research Network, Inc.
San Diego, California, 92103, United States
MD Clinical
Hallandale, Florida, 33009, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2011
First Posted
August 1, 2011
Study Start
June 16, 2011
Primary Completion
November 4, 2011
Study Completion
November 4, 2011
Last Updated
October 30, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.