Adding Atomoxetine To Standard Medication Treatment In Patients With Alzheimer's Disease

NCT ID: NCT00191009

Last Updated: 2007-11-06

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/PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-01-31

Brief Summary

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This study will compare atomoxetine to placebo when taken with current standard Alzheimer's Disease medications. The treatment will take approximately 6 months and it is hypothesized atomoxetine will significantly improve cognitive performance as compared to placebo.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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atomoxetine hydrochloride

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient presents with Alzheimer's Disease based on clinical history.
* Patient must have a Mini Mental Status Score between 10 and 26.
* Patient must have a reliable caregiver in frequent or daily contact with the patient.
* Patient must be currently treated with and on a stable dose of a standard Alzheimer's drug treatment for at least 3 months.

Exclusion Criteria

* Patients who are receiving pharmacologic treatments (other than a cholinesterase inhibitor or memantine) for Alzheimer's Disease.
* Patients who have a history in the past 5 years or any current evidence of major psychiatric illness.
* Patients who have narrow angle glaucoma.
* Patients who are experiencing clinically significant urinary hesitancy or retention as assessed by a physician.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Sherman Oaks, California, United States

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Rochester, New York, United States

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Wichita Falls, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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B4Z-MC-LYCG

Identifier Type: -

Identifier Source: secondary_id

7951

Identifier Type: -

Identifier Source: org_study_id