Completed
Estrogen Hormone Protocol
0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested
Estrogen
Drug
Who is being recruted
Alzheimer Disease
Over 60 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: October 1995
See protocol details
Summary
Principal SponsorNational Institute on Aging (NIA)
Last updated: December 11, 2009
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 1995Actual date on which the first participant was enrolled.
Estrogen is a hormone that is dominant in the female reproductive system. In women, most estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into estrogen. Because this hormone also has many beneficial effects on brain cells, it currently is being studied as a treatment for Alzheimer's disease. The enzyme that forms the neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small clinical studies have demonstrated improvement in cognitive function and mood measures in women with Alzheimer's disease who take estrogen.
Principal SponsorNational Institute on Aging (NIA)
Last updated: December 11, 2009
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
120 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.
Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.
Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alzheimer Disease
Criteria
1 inclusion criteria required to participate
Women with a diagnosis of Alzheimer's disease who currently are not taking estrogen replacement therapy, who have had a hysterectomy, and who are in stable general health
1 exclusion criteria prevent from participating
Patients with an uncontrolled health problem, such as untreated high blood pressure or thyroid disease
Ensure optimum compatibilityAdd your profile to know your probability eligibility score.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 25 locations
Suspended
Suspended
University of California, San DiegoSan Diego, United States
Suspended
Mayo Clinic JacksonvilleJacksonville, United States
Suspended
University of South FloridaTampa, United States
Completed25 Study Centers