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

NCT ID: NCT00948909

Last Updated: 2013-01-31

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

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-11-30

Brief Summary

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

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Detailed Description

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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

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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A. Sugar Pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo intervention

B. ABT-126

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

Experimental intervention

C. ABT-126

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

Experimental intervention

D. donepezil

Group Type ACTIVE_COMPARATOR

donepezil

Intervention Type DRUG

Active comparator intervention

Interventions

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Placebo

Placebo intervention

Intervention Type DRUG

ABT-126

Experimental intervention

Intervention Type DRUG

donepezil

Active comparator intervention

Intervention Type DRUG

Other Intervention Names

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Sugar Pill Aricept

Eligibility Criteria

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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).
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# 19904

Fresno, California, United States

Site Status

Site Reference ID/Investigator# 23025

West Palm Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 19905

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 22944

Pleven, , Bulgaria

Site Status

Site Reference ID/Investigator# 22942

Plovdiv, , Bulgaria

Site Status

Site Reference ID/Investigator# 22945

Sofia, , Bulgaria

Site Status

Site Reference ID/Investigator# 22946

Sofia, , Bulgaria

Site Status

Site Reference ID/Investigator# 20276

Litoměřice, , Czechia

Site Status

Site Reference ID/Investigator# 20273

Pilsen, , Czechia

Site Status

Site Reference ID/Investigator# 20274

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 20272

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 20701

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 23625

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 23624

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 23622

Michalovce, , Slovakia

Site Status

Site Reference ID/Investigator# 23942

Rimavská Sobota, , Slovakia

Site Status

Site Reference ID/Investigator# 20267

Belville, , South Africa

Site Status

Site Reference ID/Investigator# 20266

Cape Town, , South Africa

Site Status

Site Reference ID/Investigator# 20261

Durban, , South Africa

Site Status

Site Reference ID/Investigator# 21682

George, , South Africa

Site Status

Site Reference ID/Investigator# 20265

Johannesburg, , South Africa

Site Status

Site Reference ID/Investigator# 20271

Port Elizabeth, , South Africa

Site Status

Site Reference ID/Investigator# 20263

Richards Bay, , South Africa

Site Status

Site Reference ID/Investigator# 20187

Blackburn, , United Kingdom

Site Status

Site Reference ID/Investigator# 20183

Bradford, , United Kingdom

Site Status

Site Reference ID/Investigator# 20191

Crowborough, , United Kingdom

Site Status

Site Reference ID/Investigator# 20184

Glasgow, , United Kingdom

Site Status

Site Reference ID/Investigator# 20190

London, , United Kingdom

Site Status

Site Reference ID/Investigator# 20192

Southampton, , United Kingdom

Site Status

Countries

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United States Bulgaria Czechia Slovakia South Africa United Kingdom

References

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Gault LM, Ritchie CW, Robieson WZ, Pritchett Y, Othman AA, Lenz RA. A phase 2 randomized, controlled trial of the alpha7 agonist ABT-126 in mild-to-moderate Alzheimer's dementia. Alzheimers Dement (N Y). 2015 Jun 23;1(1):81-90. doi: 10.1016/j.trci.2015.06.001. eCollection 2015 Jun.

Reference Type DERIVED
PMID: 29854928 (View on PubMed)

Other Identifiers

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2009-011424-64

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-984

Identifier Type: -

Identifier Source: org_study_id

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