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A Safety and Tolerability Study of ABT-126 in Elderly

NCT ID: NCT00867399

Last Updated: 2010-11-02

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

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.

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

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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20mg of ABT-126 QD

20 mg of ABT-126 QD for 10 days

Group Type ACTIVE_COMPARATOR

ABT-126

Intervention Type DRUG

See arm for details

30mg and 45mg ABT-126 QD

30 mg and 45mg of ABT-126 QD for 21 days

Group Type ACTIVE_COMPARATOR

ABT-126

Intervention Type DRUG

See arm for details

Interventions

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ABT-126

See arm for details

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subjects 65 years or greater.
* Has a MMSE score of 27 or higher.

Exclusion Criteria

* History of dementia including by not limited to Alzheimer's disease, Parkinson's disease and mult-infarct dementia.
* History of any significant neurological disease.
* Has an estimated creatinine clearance \< 30 mL/min
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Locations

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Site Reference ID/Investigator# 17283

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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M10-717

Identifier Type: -

Identifier Source: org_study_id