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Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
This study has been completed.
Study NCT00065767   Information provided by National Institute on Aging (NIA)
First Received: July 31, 2003   Last Updated: June 23, 2009   History of Changes

July 31, 2003
June 23, 2009
September 2001
 
 
 
Complete list of historical versions of study NCT00065767 on ClinicalTrials.gov Archive Site
 
 
 
Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

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.

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.

Phase II, Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Alzheimer Disease
Drug: Raloxifene
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
20
December 2004
 

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
Female
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065767
 
IA0049, IRB M1285
University of Wisconsin, Madison
 
Principal Investigator: Sanjay Asthana, MD William S. Middleton VA Hospital, University of Wisconsin Memory Research Program
National Institute on Aging (NIA)
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP