Back to resultsA Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease (AD) Taking a Stable Dose of Donepezil
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ASP0777
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring ASP0777, Alzheimer's Disease
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
Sites / Locations
- Pacific Research Network, Inc.
- MD Clinical
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ASP0777 low dose
ASP0777 low dose, then high dose
ASP0777 high dose
Placebo
Arm Description
ASP0777 low dose for 6 weeks
ASP0777 low dose for 1 week and ASP0777 high dose for 5 weeks
ASP0777 high dose for 6 weeks
Placebo for 6 weeks
Outcomes
Primary Outcome Measures
Number and percentage of subjects with adverse events
Secondary Outcome Measures
Pharmacokinetic assessment of AUC, maximum concentration (Cmax), minimum concentration (Cmin) and time to maximum concentration (tmax) through analysis of blood samples
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01406145
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 16, 2011 (Actual)
Primary Completion Date
November 4, 2011 (Actual)
Study Completion Date
November 4, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
ASP0777, Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP0777 low dose
Arm Type
Experimental
Arm Description
ASP0777 low dose for 6 weeks
Arm Title
ASP0777 low dose, then high dose
Arm Type
Experimental
Arm Description
ASP0777 low dose for 1 week and ASP0777 high dose for 5 weeks
Arm Title
ASP0777 high dose
Arm Type
Experimental
Arm Description
ASP0777 high dose for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 6 weeks
Intervention Type
Drug
Intervention Name(s)
ASP0777
Intervention Description
oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
Number and percentage of subjects with adverse events
Time Frame
Up to 56 Days
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Research Network, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=296
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
A Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease (AD) Taking a Stable Dose of Donepezil
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