Adding Atomoxetine To Standard Medication Treatment In Patients With Alzheimer's Disease - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191009

Purpose

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.

Condition	Intervention	Phase
Alzheimer Disease	Drug: atomoxetine hydrochloride Drug: placebo	Phase II Phase III

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Atomoxetine Augmentation of Cholinesterase Inhibitor Therapy in Patients With Alzheimer's Disease

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To see if Alzheimer's patients receiving a stable dose of an Alzheimer's drug randomly assigned to atomoxetine for approximately 6 months will have cognitive performance improved as measured by the Alzheimer's Disease Assessment Scale - Cognitive

Secondary Outcome Measures:

To see if patients taking an Alzheimer's medication plus atomoxetine for approximately 6 months will be superior to an Alzheimer's medication alone as assessed by the Clinician's Interview-Based Impression of Change (CIBIC+) score.
To see if patients taking an Alzheimer's medication plus atomoxetine will display less comorbid psychological symptoms, such as depression, as assessed by the Neuropsychiatric Inventory (NPI). Patients will receive the NPI once before randomization
To see if current Alzheimer's medications plus atomoxetine compared to Alzheimer's medications plus placebo is better at preserving or slowing cognitive decline as measured by the Alzheimer's Disease Cooperative Study Inventory - Activities of
To show that current Alzheimer's drugs can be taken with atomoxetine without significant side effects.

Estimated Enrollment:	124
Study Start Date:	October 2003
Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191009

Locations

United States, California
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
United States, New York
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
United States, Texas
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

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	7951, B4Z-MC-LYCG
Study First Received:	September 12, 2005
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00191009
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Atomoxetine
Central Nervous System Diseases

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors

Physiological Effects of Drugs
Nervous System Diseases
Tauopathies
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009