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

June 1, 2018 updated by: AbbVie (prior sponsor, Abbott)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Kazan, Russian Federation, 420012
        • Site Reference ID/Investigator# 22687
      • Moscow, Russian Federation, 115522
        • Site Reference ID/Investigator# 22636
      • Moscow, Russian Federation, 123995
        • Site Reference ID/Investigator# 23702
      • Saratov, Russian Federation, 410060
        • Site Reference ID/Investigator# 22689
      • St. Petersburg, Russian Federation, 190005
        • Site Reference ID/Investigator# 22635
      • St. Petersburg, Russian Federation, 190103
        • Site Reference ID/Investigator# 22633
      • St. Petersburg, Russian Federation, 190121
        • Site Reference ID/Investigator# 22637
      • St. Petersburg, Russian Federation, 192019
        • Site Reference ID/Investigator# 22632
      • St. Petersburg, Russian Federation, 192019
        • Site Reference ID/Investigator# 22634
      • St. Petersburg, Russian Federation, 194044
        • Site Reference ID/Investigator# 24563
  • Ukraine
      • Dnipropetrovs'k, Ukraine, 49027
        • Site Reference ID/Investigator# 22630
      • Donetsk, Ukraine
        • Site Reference ID/Investigator# 22625
      • Glevakha, Ukraine, 08631
        • Site Reference ID/Investigator# 22624
      • Kharkiv, Ukraine, 61168
        • Site Reference ID/Investigator# 22629
      • Kherson, Ukraine, 73488
        • Site Reference ID/Investigator# 24565
      • Kiev, Ukraine, 04112
        • Site Reference ID/Investigator# 24566
      • Kiev, Ukraine, 04114
        • Site Reference ID/Investigator# 22622
      • Kiev, Ukraine, 05113
        • Site Reference ID/Investigator# 22623
      • Lugansk, Ukraine, 91045
        • Site Reference ID/Investigator# 22628
      • Odessa, Ukraine, 65006
        • Site Reference ID/Investigator# 43143
      • Poltava, Ukraine, 36006
        • Site Reference ID/Investigator# 22627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: sugar pill
Drug: placebo
Subjects will take 4 capsules once daily for 12 weeks.
Active Comparator: donepezil
Drug: donepezil
Subjects will take 4 capsules once daily for 12 weeks.
Other Names:
  • Aricept
Experimental: Arm 1, Dose 1, ABT-288
Low Dose
Drug: ABT-288
Subjects will take 4 capsules once daily for 12 weeks.
Experimental: Arm 2, Dose 2, ABT-288
High dose
Drug: ABT-288
Subjects will take 4 capsules once daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion
Time Frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD

Secondary Outcome Measures

Outcome Measure
Time Frame
MMSE: Mini Mental Status Exam
Time Frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
NPI: Neuropsychiatric Inventory
Time Frame: Day -1, Weeks 4,8, 12/PD
Day -1, Weeks 4,8, 12/PD
ADCS-ADL: Alzheimer's Disease Cooperative Study
Time Frame: Day -1, Weeks 4,8 & 12/PD
Day -1, Weeks 4,8 & 12/PD
CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus
Time Frame: Day -1, Weeks 4,8 & 12/PD]
Day -1, Weeks 4,8 & 12/PD]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: George Haig, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (Estimate)

November 24, 2009

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-822
  • 2009-010704-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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