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

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

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease Hormone Replacement Therapy

ChemIDplus related topics:

Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Progesterone Medroxyprogesterone Medroxyprogesterone 17-acetate

U.S. FDA Resources

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

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

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
First Received:	August 4, 2003
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00066157
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Alzheimer disease

Hormone replacement therapy

Postmenopausal women

Study placed in the following topic categories:

Medroxyprogesterone 17-Acetate

Progesterone

Benzoates

Alzheimer Disease

Estradiol valerate

Central Nervous System Diseases

Estradiol 17 beta-cypionate

Brain Diseases

Neurodegenerative Diseases

Estradiol

Cognition Disorders

Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders

Estradiol 3-benzoate

Medroxyprogesterone

Polyestradiol phosphate

Dementia

Delirium

Additional relevant MeSH terms:

Estrogens

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Contraceptive Agents

Nervous System Diseases

Physiological Effects of Drugs

Contraceptives, Oral

Hormones, Hormone Substitutes, and Hormone Antagonists

Contraceptive Agents, Female

Reproductive Control Agents

Contraceptive Agents, Male

Hormones

Pharmacologic Actions

Therapeutic Uses

Contraceptives, Oral, Synthetic

Tauopathies

ClinicalTrials.gov processed this record on September 05, 2008

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