Alzheimer's Disease: Therapeutic Potential of Estrogen - Full Text View

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00066157

Purpose

This is a 15-month study to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.

Condition	Intervention	Phase
Alzheimer Disease	Drug: Transdermal estradiol Drug: Medroxyprogesterone Drug: Placebo Patch Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Alzheimer's Disease: Therapeutic Potential of Estrogen

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Hormone Replacement Therapy

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Medroxyprogesterone 17-acetate Estradiol dipropionate Estradiol cypionate Medroxyprogesterone Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change [ Time Frame: Baseline and 1, 3, 6, 12, and 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Skills of Independent Living: Physical functioning Performance (PFP) [ Time Frame: Baseline and 1, 3, 6, 12, and 15 months ] [ Designated as safety issue: No ]
Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen) [ Time Frame: Baseline and 1, 3, 6, 12, and 15 months ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	September 2001
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental estradiol patch and medroxyprogesterone	Drug: Transdermal estradiol 50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months Drug: Medroxyprogesterone 2.5mg tablet daily for 12 months
2: Active Comparator estradiol patch and placebo pill	Drug: Transdermal estradiol 50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months Drug: Placebo Placebo tablet daily for 12 months
3: Active Comparator placebo patch and medroxyprogesterone	Drug: Medroxyprogesterone 2.5mg tablet daily for 12 months Drug: Placebo Patch Transdermal placebo patch, changed every 3 days, for 12 months
4: Placebo Comparator placebo patch and placebo pill	Drug: Placebo Patch Transdermal placebo patch, changed every 3 days, for 12 months Drug: Placebo Placebo tablet daily for 12 months

Detailed Description:

Estrogen is a naturally occurring hormone produced in a woman's body. The purpose of this 15-month study is to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease and without other dementias.

Patients who volunteer for this study will either receive a patch containing 17-ß-estradiol or will receive an inactive placebo patch. In addition, patients will be given either medroxyprogesterone or an inactive placebo pill. Neither the volunteers nor the study staff will know which type of patch or 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 medications on schedule. 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 160 participants are being recruited.

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 State Examination score greater than 15/30

Exclusion Criteria:

History of cancer of reproductive tissues
History of deep vein thrombosis or blot clots
Diabetes
Heart disease or stroke
Liver problems including hepatitis
Severe vision or hearing problems
Tobacco use
Lack of an adequate caregiver
inability to perform psychometric testing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066157

Locations

United States, Wisconsin
University of Wisconsin Memory Research Program
Madison, Wisconsin, United States, 53705

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Sanjay Asthana, MD

University of Wisconsin - Madison, William S. Middleton VA Hospital

More Information

Additional Information:

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

Publications:

Cholerton B, Gleason CE, Baker LD, Asthana S. Estrogen and Alzheimer's disease: the story so far. Drugs Aging. 2002;19(6):405-27. Review.

Asthana S, Baker LD, Craft S, Stanczyk FZ, Veith RC, Raskind MA, Plymate SR. High-dose estradiol improves cognition for women with AD: results of a randomized study. Neurology. 2001 Aug 28;57(4):605-12.

Asthana S, Craft S, Baker LD, Raskind MA, Birnbaum RS, Lofgreen CP, Veith RC, Plymate SR. Cognitive and neuroendocrine response to transdermal estrogen in postmenopausal women with Alzheimer's disease: results of a placebo-controlled, double-blind, pilot study. Psychoneuroendocrinology. 1999 Aug;24(6):657-77.

Responsible Party:	University of Wisconsin-Madison Medical School ( Sanjay Asthana, MD, FRCP(C) )
Study ID Numbers:	IA0048, FDA IRB approval M1285, NIH grant AG17196-03
Study First Received:	August 4, 2003
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00066157 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Alzheimer disease
Hormone replacement therapy
Postmenopausal women

Additional relevant MeSH terms:

Medroxyprogesterone 17-Acetate
Antineoplastic Agents
Contraceptive Agents
Contraceptives, Oral
Estradiol valerate
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Estradiol 17 beta-cypionate
Reproductive Control Agents
Contraceptive Agents, Male
Neurodegenerative Diseases
Brain Diseases
Hormones
Mental Disorders

Estradiol 3-benzoate
Therapeutic Uses
Contraceptives, Oral, Synthetic
Polyestradiol phosphate
Dementia
Estrogens
Antineoplastic Agents, Hormonal
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Estradiol
Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
Medroxyprogesterone
Tauopathies

ClinicalTrials.gov processed this record on November 09, 2009