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Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease

NCT ID: NCT01527916

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 410 adults with mild to moderate Alzheimer's disease. Subjects will be randomized to one of 5 treatment groups (ABT-126, donepezil or placebo) for a 24-week treatment period.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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sugar pill

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo Comparator

donepezil

Group Type ACTIVE_COMPARATOR

donepezil

Intervention Type DRUG

Active Comparator

ABT-126 Low Dose

low dose

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

low dose, middle dose, high dose

ABT-126 Middle Dose

middle dose

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

low dose, middle dose, high dose

ABT-126 high dose

high dose

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

low dose, middle dose, high dose

Interventions

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placebo

Placebo Comparator

Intervention Type DRUG

donepezil

Active Comparator

Intervention Type DRUG

ABT-126

low dose, middle dose, high dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject.
* The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
* The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease.
* The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
* The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
* The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit 1.
* With the exception of a diagnosis of mild to moderate AD and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
* The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study.

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, or is participating in cognitive therapy for the treatment of Alzheimer's disease or dementia.
* The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator.
* The subject has a history of any significant neurologic disease other than Alzheimer's disease including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
* In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
* The subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Gault, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 56503

Delray Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 56518

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 56514

West Palm Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 62611

Elk Grove Village, Illinois, United States

Site Status

Site Reference ID/Investigator# 56506

Staten Island, New York, United States

Site Status

Site Reference ID/Investigator# 82994

Jenkintown, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 77636

Wichita Falls, Texas, United States

Site Status

Site Reference ID/Investigator# 56504

Bennington, Vermont, United States

Site Status

Site Reference ID/Investigator# 62565

Gdynia, , Poland

Site Status

Site Reference ID/Investigator# 62563

Poznan, , Poland

Site Status

Site Reference ID/Investigator# 62562

Szczecin, , Poland

Site Status

Site Reference ID/Investigator# 60945

Kazan', , Russia

Site Status

Site Reference ID/Investigator# 60955

Kazan', , Russia

Site Status

Site Reference ID/Investigator# 60954

Kirov, , Russia

Site Status

Site Reference ID/Investigator# 60951

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 60959

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 60946

Novosibirsk, , Russia

Site Status

Site Reference ID/Investigator# 60947

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 60958

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 60949

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 60952

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 60950

Saratov, , Russia

Site Status

Site Reference ID/Investigator# 60911

Belville, , South Africa

Site Status

Site Reference ID/Investigator# 76073

Cape Town, , South Africa

Site Status

Site Reference ID/Investigator# 60912

George, , South Africa

Site Status

Site Reference ID/Investigator# 60910

Johannesburg, , South Africa

Site Status

Site Reference ID/Investigator# 60909

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 60906

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 60905

Poltava, , Ukraine

Site Status

Site Reference ID/Investigator# 60960

Bath, , United Kingdom

Site Status

Site Reference ID/Investigator# 60963

Blackburn, , United Kingdom

Site Status

Site Reference ID/Investigator# 60962

Glasgow, , United Kingdom

Site Status

Site Reference ID/Investigator# 60961

London, , United Kingdom

Site Status

Countries

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United States Poland Russia South Africa Ukraine United Kingdom

References

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Gault LM, Lenz RA, Ritchie CW, Meier A, Othman AA, Tang Q, Berry S, Pritchett Y, Robieson WZ. ABT-126 monotherapy in mild-to-moderate Alzheimer's dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension. Alzheimers Res Ther. 2016 Oct 18;8(1):44. doi: 10.1186/s13195-016-0210-1.

Reference Type DERIVED
PMID: 27756421 (View on PubMed)

Other Identifiers

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2011-002004-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-985

Identifier Type: -

Identifier Source: org_study_id