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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT01406145

First received: July 6, 2011

Last updated: November 17, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 6, 2011

Last Updated Date

November 17, 2011

Start Date ^ICMJE

June 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number and percentage of subjects with adverse events [ Time Frame: Up to 56 Days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01406145 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: ASP0777
oral tablet
Drug: Placebo
oral tablet

Study Arm (s)

Experimental: ASP0777 low dose
ASP0777 low dose for 6 weeks

Intervention: Drug: ASP0777
Experimental: ASP0777 low dose, then high dose
ASP0777 low dose for 1 week and ASP0777 high dose for 5 weeks

Intervention: Drug: ASP0777
Experimental: ASP0777 high dose
ASP0777 high dose for 6 weeks

Intervention: Drug: ASP0777
Placebo Comparator: Placebo
Placebo for 6 weeks

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01406145

Other Study ID Numbers ^ICMJE

0777-CL-0030

Has Data Monitoring Committee

Responsible Party

Astellas Pharma Inc

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Astellas Pharma Global Development

Information Provided By

Astellas Pharma Inc

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top