Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease

January 24, 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-384 in Subjects With Mild-to-Moderate Alzheimer's Disease

The purpose of this study is to test if the investigational medication, ABT-384, is a safe and effective treatment for adults 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 safety and efficacy of ABT-384 in approximately 260 adults with mild-to-moderate Alzheimer's Disease (AD). Subjects will be randomized to one of four treatment groups (ABT-384, donepezil, or placebo) for a 12-week Treatment Period.

Study Type

Interventional

Enrollment (Actual)

267

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
      • Ekaterinburg, Russian Federation, 620030
        • Site Reference ID/Investigator# 40834
      • Kazan, Russian Federation, 420097
        • Site Reference ID/Investigator# 36304
      • Kirov, Russian Federation, 610014
        • Site Reference ID/Investigator# 36306
      • Moscow, Russian Federation, 119048
        • Site Reference ID/Investigator# 37944
      • Saratov, Russian Federation, 410060
        • Site Reference ID/Investigator# 26909
      • St. Petersburg, Russian Federation, 190005
        • Site Reference ID/Investigator# 26904
      • St. Petersburg, Russian Federation, 190103
        • Site Reference ID/Investigator# 26902
      • St. Petersburg, Russian Federation, 198510
        • Site Reference ID/Investigator# 36305
      • Yaroslavl, Russian Federation, 150030
        • Site Reference ID/Investigator# 38383
  • South Africa
      • Belville, South Africa, 7530
        • Site Reference ID/Investigator# 45584
      • George, South Africa, 6529
        • Site Reference ID/Investigator# 47102
      • Johannesburg, South Africa, 2196
        • Site Reference ID/Investigator# 45583
  • Ukraine
      • Donetsk, Ukraine, 83003
        • Site Reference ID/Investigator# 39855
      • Kharkiv, Ukraine, 61177
        • Site Reference ID/Investigator# 26914
      • Kiev, Ukraine, 04114
        • Site Reference ID/Investigator# 26912
      • Lviv, Ukraine, 79010
        • Site Reference ID/Investigator# 40484
      • Poltava, Ukraine, 36006
        • Site Reference ID/Investigator# 27002
      • Poltava, Ukraine, 36024
        • Site Reference ID/Investigator# 39856
      • Simferopil, Ukraine, 95006
        • Site Reference ID/Investigator# 40482
      • Ternopil, Ukraine, 46020
        • Site Reference ID/Investigator# 40483
      • Vinnytsia, Ukraine, 21005
        • Site Reference ID/Investigator# 35660
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Site Reference ID/Investigator# 36327
      • Blackburn, United Kingdom, BB2 3HH
        • Site Reference ID/Investigator# 35657
      • Crowborough, United Kingdom, TN6 1HB
        • Site Reference ID/Investigator# 36330
      • Glasgow, United Kingdom, G20 0XA
        • Site Reference ID/Investigator# 36326
      • Ivybridge, Devon, United Kingdom, PL21 9AB
        • Site Reference ID/Investigator# 44123
      • London, United Kingdom, TW8 8DS
        • Site Reference ID/Investigator# 35658
      • Northampton, United Kingdom, NN5 6UD
        • Site Reference ID/Investigator# 35902
      • Oxford, United Kingdom, OX3 9DU
        • Site Reference ID/Investigator# 36328
      • Peterborough, United Kingdom, PE2 7JU
        • Site Reference ID/Investigator# 36329

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. The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject.
  2. Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
  3. Subject meets the NINCDS/ADRDA criteria for probable AD.
  4. Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
  5. Subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
  6. 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 12-lead ECG.
  7. If female, subject must be postmenopausal for at least 2 years or surgically sterile.
  8. If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
  9. Subject has an identified reliable, caregiver (e.g., family member, social worker, nurse), who will provide support and ensure compliance with the study medication and procedures.
  10. Subject and caregiver are fluent in the language used for administration of the rating scales or cognitive tests and have sufficient visual, hearing and graphomotor skills to complete procedures.

Exclusion Criteria:

  1. Subject has a known hypersensitivity or intolerance to donepezil that led to discontinuation or a known reported history of donepezil treatment failure.
  2. Subject is currently taking or has taken a medication for the treatment of AD or dementia within 60 days of Screening Visit 1, or is participating in cognitive therapy for the treatment of AD or dementia.
  3. Subject has a history of a drug or alcohol disorder (abuse/dependence), based on either DSM-IV-TR or ICD-10 criteria, excluding nicotine, within 2 years prior to Screening Visit 1.
  4. In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness that would affect the safety of the subject.
  5. The subject has a current thyroid disease or history of thyroid disease, and is not currently being treated with a stable dose of thyroid replacement medication.
  6. For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.

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: placebo
Drug: placebo
Subjects will take study drug once daily for 12 weeks
Active Comparator: donepezil
Drug: donepezil
Subjects will take study drug once daily for 12 weeks.
Other Names:
  • Aricept
Experimental: ABT-384 Dose 1
Drug: ABT-384
Subjects will take study drug once daily for 12 weeks
Experimental: ABT-384 Dose 2
Drug: ABT-384
Subjects will take study drug once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mini Mental Status Examination (MMSE) score at Baseline, Weeks 4, 8, and 12
Time Frame: 12 Weeks
12 Weeks
Clinician's Interview Based Impression of Change-plus (CIBIC-plus) score at Baseline, Weeks 4, 8, and 12
Time Frame: 12 Weeks
12 Weeks
Neuropsychiatric Inventory (NPI) score at Baseline, Weeks 4, 8, and 12
Time Frame: 12 Weeks
12 Weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score at Baseline, Weeks 4, 8, and 12
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

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

Sponsor

AbbVie (prior sponsor, Abbott)

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

May 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

May 7, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (Estimate)

June 4, 2010

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 24, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-033
  • 2009 017801-12 (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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