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

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Lilly

Status and phase

Completed
Phase 3
Phase 2

Conditions

Alzheimer Disease

Treatments

Drug: placebo
Drug: atomoxetine hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191009
7951
B4Z-MC-LYCG

Details and patient eligibility

About

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.

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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