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Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease

NCT ID: NCT01018875

Last Updated: 2018-06-06

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

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-02-28

Brief Summary

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Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.

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Detailed Description

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1, Dose 1, ABT-288

Low Dose

Group Type EXPERIMENTAL

ABT-288

Intervention Type DRUG

Subjects will take 4 capsules once daily for 12 weeks.

Arm 2, Dose 2, ABT-288

High dose

Group Type EXPERIMENTAL

ABT-288

Intervention Type DRUG

Subjects will take 4 capsules once daily for 12 weeks.

donepezil

Group Type ACTIVE_COMPARATOR

donepezil

Intervention Type DRUG

Subjects will take 4 capsules once daily for 12 weeks.

sugar pill

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Subjects will take 4 capsules once daily for 12 weeks.

Interventions

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ABT-288

Subjects will take 4 capsules once daily for 12 weeks.

Intervention Type DRUG

donepezil

Subjects will take 4 capsules once daily for 12 weeks.

Intervention Type DRUG

placebo

Subjects will take 4 capsules once daily for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Aricept

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: 1. Have voluntarily signed an informed consent. 2. Subject meets diagnostic criteria criteria for probable AD (Alzheimer's Disease). 3. Female subjects must be postmenopausal for at least 2 years or surgically sterile. 4. Male subjects must be surgically sterile, sexually inactive or using a barrier method of birth control. 5. Subject has an identified, reliable caregiver. 6. Subject has a CT or MRI scan within 36 months prior to randomization. 7.

Exclusion Criteria

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 ECG Exclusion Criteria: 1. Subject is currently taking or has taken a medication for the treatment of AD or dementia with 60 days of Screening visit, or is participating in cognitive therapy for the treatment of AD or dementia. 2. Subject uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence. 3. Subject has a history of any significant neurologic disease other than AD. 4. Subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation. 5. Subject has received any investigation product within 6 weeks prior to study drug administration.
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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George Haig

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 22687

Kazan', , Russia

Site Status

Site Reference ID/Investigator# 22636

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 23702

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 22635

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 22633

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 22637

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 22632

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 22634

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 24563

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 22689

Saratov, , Russia

Site Status

Site Reference ID/Investigator# 22630

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 22625

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 22624

Hlevakha, , Ukraine

Site Status

Site Reference ID/Investigator# 22629

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 24565

Kherson, , Ukraine

Site Status

Site Reference ID/Investigator# 24566

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 22622

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 22623

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 22628

Luhansk, , Ukraine

Site Status

Site Reference ID/Investigator# 43143

Odesa, , Ukraine

Site Status

Site Reference ID/Investigator# 22627

Poltava, , Ukraine

Site Status

Countries

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Russia Ukraine

References

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Hung SY, Fu WM. Drug candidates in clinical trials for Alzheimer's disease. J Biomed Sci. 2017 Jul 19;24(1):47. doi: 10.1186/s12929-017-0355-7.

Reference Type BACKGROUND
PMID: 28720101 (View on PubMed)

Other Identifiers

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2009-010704-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-822

Identifier Type: -

Identifier Source: org_study_id

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