Adding Atomoxetine To Standard Medication Treatment In Patients With Alzheimer's Disease
Atomoxetine Augmentation of Cholinesterase Inhibitor Therapy in Patients With Alzheimer's Disease
2 other identifiers
interventional
124
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 alzheimer-disease
Started Oct 2003
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedNovember 6, 2007
November 1, 2007
September 12, 2005
November 5, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
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
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
October 1, 2003
Study Completion
January 1, 2006
Last Updated
November 6, 2007
Record last verified: 2007-11