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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
267

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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