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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191009
First received: September 12, 2005
Last updated: November 5, 2007
Last verified: November 2007

September 12, 2005
November 5, 2007
October 2003
Not Provided
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 ClinicalTrials.gov 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.
  • -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.
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: atomoxetine hydrochloride
  • Drug: placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
January 2006
Not Provided

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.
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00191009
7951, B4Z-MC-LYCG
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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