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The Effects of Sex Hormones on Cognition and Mood in Older Adults

NCT ID: NCT00000175

Last Updated: 2009-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Completion Date

2005-06-30

Brief Summary

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This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.

Detailed Description

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Double-blind, placebo-controlled, crossover study investigating the effects of estrogen replacement and testosterone replacement on cognition and mood in older adults. Women who have not had a hysterectomy will be given Prempro (estrogen with progesterone to protect the uterine lining), and hysterectomized women will be given Premarin (estrogen only).

Conditions

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Cognition Disorders Mood Disorders

Keywords

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Emotions Cognition Aging Memory

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Estrogen

Intervention Type DRUG

Testosterone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women and men aged 65-90 who have not received hormone replacement for the last three months.

Exclusion Criteria

* Previous head injury with loss of consciousness for more than one hour.
* Men with a history of prostate cancer.
* Men on testosterone replacement within the past three months.
* Women with a history of breast or uterine cancer.
* Women on estrogen replacement within the past three months.
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role lead

Principal Investigators

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Dr. Pauline Maki

Role: PRINCIPAL_INVESTIGATOR

National Institute on Aging, Gerontology Research Center

Locations

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Gerontology Research Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Henderson VW. The epidemiology of estrogen replacement therapy and Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 7):S27-35. doi: 10.1212/wnl.48.5_suppl_7.27s.

Reference Type BACKGROUND
PMID: 9153164 (View on PubMed)

Janowsky JS, Oviatt SK, Orwoll ES. Testosterone influences spatial cognition in older men. Behav Neurosci. 1994 Apr;108(2):325-32. doi: 10.1037//0735-7044.108.2.325.

Reference Type BACKGROUND
PMID: 8037876 (View on PubMed)

Sherwin BB. Estrogen effects on cognition in menopausal women. Neurology. 1997 May;48(5 Suppl 7):S21-6. doi: 10.1212/wnl.48.5_suppl_7.21s.

Reference Type BACKGROUND
PMID: 9153163 (View on PubMed)

Other Identifiers

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IA0016

Identifier Type: -

Identifier Source: org_study_id