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Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease | Clinical Trials | Clareo Health

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

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

NCT00948909•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

Summary

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

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

Eligibility

Age

55 - 90 years

Sex

ALL

Healthy Volunteers

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).

Locations (29)

Site Reference ID/Investigator# 19904

Fresno, California, United States

Site Reference ID/Investigator# 23025

West Palm Beach, Florida, United States

Site Reference ID/Investigator# 19905

Indianapolis, Indiana, United States

Site Reference ID/Investigator# 22944

Pleven, Bulgaria

Site Reference ID/Investigator# 22942

Plovdiv, Bulgaria

Site Reference ID/Investigator# 22945

Sofia, Bulgaria

Site Reference ID/Investigator# 22946

Sofia, Bulgaria

Site Reference ID/Investigator# 20276

Litoměřice, Czechia

Site Reference ID/Investigator# 20273

Pilsen, Czechia

Site Reference ID/Investigator# 20274

Prague, Czechia

Key Dates

Start Date

October 1, 2009

Primary Completion Date

November 1, 2010

Completion Date

November 1, 2010

Last Updated

January 31, 2013

Enrollment

274

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

Placebo

DRUG

ABT-126

DRUG

donepezil

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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