Skip to main content
OpenTrials
Completed

NCT Number: NCT01018875

Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease

Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 22687, Kazan', Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1. Have voluntarily signed an informed consent. 2. Subject meets diagnostic criteria criteria for probable AD (Alzheimer's Disease). 3. Female subjects must be postmenopausal for at least 2 years or surgically sterile. 4. Male subjects must be surgically sterile, sexually inactive or using a barrier method of birth control. 5. Subject has an identified, reliable caregiver. 6. Subject has a CT or MRI scan within 36 months prior to randomization. 7. With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, the subject is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and ECG Exclusion Criteria: 1. Subject is currently taking or has taken a medication for the treatment of AD or dementia with 60 days of Screening visit, or is participating in cognitive therapy for the treatment of AD or dementia. 2. Subject uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence. 3. Subject has a history of any significant neurologic disease other than AD. 4. Subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation. 5. Subject has received any investigation product within 6 weeks prior to study drug administration.

Treatment and study plan

ABT-288

Drug

Subjects will take 4 capsules once daily for 12 weeks.

Donepezil

Drug

Subjects will take 4 capsules once daily for 12 weeks.

Other names: Aricept

Placebo

Drug

Subjects will take 4 capsules once daily for 12 weeks.

Primary outcomes

  1. ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion

    Time frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD

Secondary outcomes

  1. MMSE: Mini Mental Status Exam

    Time frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD

  2. NPI: Neuropsychiatric Inventory

    Time frame: Day -1, Weeks 4,8, 12/PD

  3. ADCS-ADL: Alzheimer's Disease Cooperative Study

    Time frame: Day -1, Weeks 4,8 & 12/PD

  4. CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus

    Time frame: Day -1, Weeks 4,8 & 12/PD]

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

A Randomized, Double-Blind, Active- and Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 24, 2009
Registry last updated
Jun 6, 2018

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.

Published trials that share one or more normalized conditions with this study.