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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00191009
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : November 6, 2007
Information provided by:
Eli Lilly and Company

September 12, 2005
September 19, 2005
November 6, 2007
October 2003
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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
Same as current
Complete list of historical versions of study NCT00191009 on Archive Site
  • 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.
Same as current
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Adding Atomoxetine To Standard Medication Treatment In Patients With Alzheimer's Disease
Atomoxetine Augmentation of Cholinesterase Inhibitor Therapy in Patients With Alzheimer's Disease
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.
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Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: atomoxetine hydrochloride
  • Drug: placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2006
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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.
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Eli Lilly and Company
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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
Eli Lilly and Company
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP