This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
  Purpose
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.

Condition Intervention Phase
Alzheimer Disease Drug: atomoxetine hydrochloride Drug: placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Atomoxetine Augmentation of Cholinesterase Inhibitor Therapy in Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 124
Study Start Date: October 2003
Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191009

Locations
United States, California
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
United States, New York
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
United States, Texas
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00191009     History of Changes
Other Study ID Numbers: 7951
B4Z-MC-LYCG
Study First Received: September 12, 2005
Last Updated: November 5, 2007

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Atomoxetine Hydrochloride
Cholinesterase Inhibitors
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents

ClinicalTrials.gov processed this record on September 21, 2017