Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

This study has been completed.

Sponsor:

Collaborator:

National Institute on Aging (NIA)

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

History of Changes

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Memory

Drug Information available for: Raloxifene hydrochloride

U.S. FDA Resources

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

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

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Sanjay Asthana, MD

William S. Middleton VA Hospital, University of Wisconsin Memory Research Program

More Information

Additional Information:

Wisconsin Comprehensive Memory Research Program This link exits the ClinicalTrials.gov site

Publications:

Birge SJ, McEwen BS, Wise PM. Effects of estrogen deficiency on brain function. Implications for the treatment of postmenopausal women. Postgrad Med. 2001 Mar;Spec No:11-6. Review.

Zec RF, Trivedi MA. The effects of estrogen replacement therapy on neuropsychological functioning in postmenopausal women with and without dementia: a critical and theoretical review. Neuropsychol Rev. 2002 Jun;12(2):65-109. Review.

Yaffe K. Estrogens, selective estrogen receptor modulators, and dementia: what is the evidence? Ann N Y Acad Sci. 2001 Dec;949:215-22. Review.

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
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on May 21, 2013

To Top