Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01406145
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ASP0777 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 16, 2011
Actual Primary Completion Date : November 4, 2011
Actual Study Completion Date : November 4, 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Donepezil

Arm Intervention/treatment
Experimental: ASP0777 low dose
ASP0777 low dose for 6 weeks
Drug: ASP0777
oral tablet

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

Experimental: ASP0777 high dose
ASP0777 high dose for 6 weeks
Drug: ASP0777
oral tablet

Placebo Comparator: Placebo
Placebo for 6 weeks
Drug: Placebo
oral tablet




Primary Outcome Measures :
  1. Number and percentage of subjects with adverse events [ Time Frame: Up to 56 Days ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406145


Locations
Layout table for location information
United States, California
Pacific Research Network, Inc.
San Diego, California, United States, 92103
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Layout table for investigator information
Study Director: Medical Director Astellas Pharma Global Development

Additional Information:
Layout table for additonal information
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01406145     History of Changes
Other Study ID Numbers: 0777-CL-0030
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://www.clinicalstudydatarequest.com/

Keywords provided by Astellas Pharma Inc:
ASP0777
Alzheimer's Disease

Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents