Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00065767
First received: July 31, 2003
Last updated: September 27, 2010
Last verified: September 2010
  Purpose

The aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication approved by the Food and Drug Administration for the treatment of osteoporosis, in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.


Condition Intervention Phase
Alzheimer Disease
Drug: Raloxifene
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Estimated Enrollment: 20
Study Start Date: September 2001
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Detailed Description:

The aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication (classified as Selective Estrogen Receptor Modulators (SER's)) approved by the Food and Drug Administration for the treatment of osteoporosis, in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease. Patients who volunteer for this study will need to visit the clinic 7 times (participate) over a period of five months and will receive either raloxifene or a harmless, inactive pill called a placebo. Neither the volunteers nor the study staff will know which type of pill a patient receives. Patients must be generally healthy and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side effects and ensure that the patient takes the study pills on schedule over a period of three months.

Patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. Each visit will last approximately 3 hours. A total of 20 patients is being recruited to participate in this study at the University of Wisconsin.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)
  • Mini Mental Status Exam score greater than 15/30

Exclusion Criteria:

  • History of deep vein thrombosis or blot clots
  • Diabetes
  • Active heart disease or stroke
  • Liver problems including hepatitis
  • Severe vision or hearing problems
  • Tobacco use
  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: NCT00065767

Locations
United States, Wisconsin
University of Wisconsin Memory Research Program
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Sanjay Asthana, MD William S. Middleton VA Hospital, University of Wisconsin Memory Research Program
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00065767     History of Changes
Other Study ID Numbers: IA0049, 1R01AG029624-01, IRB M1285
Study First Received: July 31, 2003
Last Updated: September 27, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
Alzheimer disease
Postmenopausal women
Hormone therapy

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Raloxifene
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 27, 2014