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

Study Overview
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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.

Official Title
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Atomoxetine Augmentation of Cholinesterase Inhibitor Therapy in Patients With Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: atomoxetine hydrochloride
* Drug: placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: atomoxetine hydrochloride|nan|
|Drug: placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |