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Completed

NCT Number: NCT01406145

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pacific Research Network, Inc., San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP0777

Drug

oral tablet

Placebo

Drug

oral tablet

Primary outcomes

  1. Number and percentage of subjects with adverse events

    Time frame: 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

    Time frame: Up to 56 Days

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 1, 2011
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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