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Hormone Therapy

Menopausal Hormone Therapy (mHT) Group for Alzheimer's Dementia (KEEPS Trial)

Phase 4
Waitlist Available
Led By Kejal Kantarci, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

KEEPS Trial Summary

This trial looks at the effects of hormone therapy and aging on cognition and brain structure in women, 9 years after the original trial.

Eligible Conditions
  • Alzheimer's Dementia

KEEPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AV-1451
Aβ PET SUVR
Global cognitive function
+2 more

KEEPS Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo GroupExperimental Treatment4 Interventions
Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive placebo treatment will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing.
Group II: Menopausal Hormone Therapy (mHT) GroupExperimental Treatment4 Interventions
Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive menopausal hormone therapy (mHT) will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brain Magnetic Resonance Imaging (MRI)
2019
Completed Phase 4
~300
F-18 Florbetapir Positron Emission Tomography (PET) Imaging
2019
Completed Phase 4
~300
F-18 AV-1451 Positron Emission Tomography (PET) Imaging
2019
Completed Phase 4
~300

Find a Location

Who is running the clinical trial?

Columbia UniversityOTHER
1,433 Previous Clinical Trials
2,460,716 Total Patients Enrolled
Banner Alzheimer's InstituteOTHER
7 Previous Clinical Trials
2,385 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,364 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being included in this research experiment?

"At present, this research project is not actively accepting participants. Originally posted on the 22nd of May 2019 and last updated on September 27th 2022, other alternatives with Alzheimer's disease have 546 trials in progress whereas F-18 Florbetapir has 3 open studies that are searching for volunteers."

Answered by AI

What previous research has utilized F-18 Florbetapir to explore potential treatments?

"F-18 Florbetapir was first clinically examined in 2019 at Banner Health. There are currently 35 completed case studies and 3 trials that are actively enrolling patients, primarily based out of San Francisco, California."

Answered by AI

Are there multiple facilities carrying out this research within the state's borders?

"The University of California San Francisco, Brigham and Women's Hospital in Boston, as well as Yale University in New Haven are three sites amongst the other 6 locations where patients can enroll for this trial."

Answered by AI

Are there any open slots for enrollment in this clinical trial?

"This clinical trial is no longer enrolling participants. It was initially posted on May 22, 2019 and the last entries were added on September 27th 2022. Those looking for other studies may want to take a look at 546 trials studying Alzheimer's disease or any of the 3 F-18 Florbetapir related projects that are still actively accepting patients."

Answered by AI

Has F-18 Florbetapir been authorized by the FDA?

"There is substantial evidence that F-18 Florbetapir is safe, making it eligible for a score of 3 on our scale. This Phase 4 trial confirms the drug's approval status."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)
Kejal Kantarci 2019. "Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03718494.
~51 spots leftby Apr 2025
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