Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease

January 29, 2013 updated by: AbbVie (prior sponsor, Abbott)

A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild-to-Moderate Alzheimer's Disease

This is a efficacy and safety study evaluating new treatment for subjects with mild to moderate Alzheimer's Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 260 adults with mild-to-moderate Alzheimer's disease (AD). Subjects will be randomized to one of the four treatment groups (ABT-126, donepezil, or placebo) for a 12-week Treatment Period. Acronyms are listed in the secondary outcome section, below, you will find a list of the acronyms defined:

  • MMSE - Mini Mental Status Exam
  • QoL-AD - Quality of Life - Alzheimer's Disease
  • CIBIC-plus - Clinician Interview-Based Impression of Change
  • NPI - Neuropsychiatric Inventory
  • CSDD - The Cornell Scale for depression in Dementia
  • ADCS-ADL - Alzheimer's Disease Cooperative Study - Activities of Daily Living

Study Type

Interventional

Enrollment (Actual)

274

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

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Site Reference ID/Investigator# 22944
      • Plovdiv, Bulgaria, 4000
        • Site Reference ID/Investigator# 22942
      • Sofia, Bulgaria, 1113
        • Site Reference ID/Investigator# 22945
      • Sofia, Bulgaria, 1431
        • Site Reference ID/Investigator# 22946
  • Czech Republic
      • Litomerice, Czech Republic, 412 01
        • Site Reference ID/Investigator# 20276
      • Plzen, Czech Republic, 301 36
        • Site Reference ID/Investigator# 20273
      • Prague 10, Czech Republic, 100 00
        • Site Reference ID/Investigator# 20274
      • Prague 2, Czech Republic, 120 00
        • Site Reference ID/Investigator# 20272
      • Prague 5, Czech Republic, 15006
        • Site Reference ID/Investigator# 20701
  • Slovakia
      • Bratislava, Slovakia, 82606
        • Site Reference ID/Investigator# 23625
      • Bratislava, Slovakia
        • Site Reference ID/Investigator# 23624
      • Michalovce, Slovakia, 07101
        • Site Reference ID/Investigator# 23622
      • Rimavska Sobota, Slovakia, 979 12
        • Site Reference ID/Investigator# 23942
  • South Africa
      • Belville, South Africa, 7530
        • Site Reference ID/Investigator# 20267
      • Cape Town, South Africa, 7500
        • Site Reference ID/Investigator# 20266
      • Durban, South Africa, 4001
        • Site Reference ID/Investigator# 20261
      • George, South Africa, 6529
        • Site Reference ID/Investigator# 21682
      • Johannesburg, South Africa, 2196
        • Site Reference ID/Investigator# 20265
      • Port Elizabeth, South Africa, 6001
        • Site Reference ID/Investigator# 20271
      • Richards Bay, South Africa, 3900
        • Site Reference ID/Investigator# 20263
  • United Kingdom
      • Blackburn, United Kingdom, BB2 3HH
        • Site Reference ID/Investigator# 20187
      • Bradford, United Kingdom, BD3 0DQ
        • Site Reference ID/Investigator# 20183
      • Crowborough, United Kingdom, TN6 1HB
        • Site Reference ID/Investigator# 20191
      • Glasgow, United Kingdom, G20 0XA
        • Site Reference ID/Investigator# 20184
      • London, United Kingdom, TW8 8DS
        • Site Reference ID/Investigator# 20190
      • Southampton, United Kingdom, SO30 3JB
        • Site Reference ID/Investigator# 20192
  • United States
    • California
      • Fresno, California, United States, 93720
        • Site Reference ID/Investigator# 19904
    • Florida
      • West Palm Beach, Florida, United States, 33407
        • Site Reference ID/Investigator# 23025
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Site Reference ID/Investigator# 19905

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:

  • The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
  • The subject meets the NINCDS/ADRDA criteria for probable AD.
  • The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
  • The subject has a Modified Hachinski Ischemic Scale (MHIS) score of less than or equal to 4 at Screening Visit 1.
  • If female, subject must be postmenopausal for at least two years or surgically sterile
  • The subject has an identified, reliable, caregiver.

Exclusion Criteria:

  • The subject is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1
  • The subject has a history of any significant neurologic disease other than AD.
  • In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
  • The subject has reported history of discontinuation of donepezil due to lack of efficacy.
  • The subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation.
  • The subject has a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients in either donepezil hydrochloride or ABT-126 formulations.
  • Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence.
  • Subjects with AST and ALT values at Screening Visit 1 that are greater than or equal to 1.5-fold the upper limit of normal (ULN).

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A. Sugar Pill
Drug: Placebo
Placebo intervention
Other Names:
  • Sugar Pill
Experimental: B. ABT-126
Drug: ABT-126
Experimental intervention
Experimental: C. ABT-126
Drug: ABT-126
Experimental intervention
Active Comparator: D. donepezil
Drug: donepezil
Active comparator intervention
Other Names:
  • Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion
Time Frame: Measurements up through 12 weeks.
Measurements up through 12 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
MMSE, QoL-AD, CIBIC-plus, NPI, CSDD, ADAS-Cog (13 item) and ADCS-ADL. Note: Acronyms are fully defined in the area titled Detailed Description.
Time Frame: Measurements up through 12 weeks.
Measurements up through 12 weeks.

Collaborators and Investigators

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

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Laura Gault, MD, 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

October 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

July 24, 2009

First Submitted That Met QC Criteria

July 28, 2009

First Posted (Estimate)

July 29, 2009

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-984
  • 2009-011424-64 (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.

Clinical Trials on Alzheimer's Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe