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

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AbbVie

Status and phase

Completed
Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: ABT-288
Drug: placebo
Drug: donepezil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01018875
M10-822
2009-010704-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

242 patients

Sex

All

Ages

55 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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. 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

242 participants in 4 patient groups, including a placebo group

Arm 1, Dose 1, ABT-288
Experimental group
Description:
Low Dose
Treatment:
Drug: ABT-288
Arm 2, Dose 2, ABT-288
Experimental group
Description:
High dose
Treatment:
Drug: ABT-288
donepezil
Active Comparator group
Treatment:
Drug: donepezil
sugar pill
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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