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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
  Purpose

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 Intervention Phase
Alzheimer's Disease
 Drug: ASP0777
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406145

Locations
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
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01406145     History of Changes
Other Study ID Numbers: 0777-CL-0030
Study First Received: July 6, 2011
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013