Personalized intervention for menopausal women at risk of dementia
Official title: Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk
Run by University of Chicago · NCT06965686 · Data updated 2026-11-12
This study is testing a new support program for middle-aged women going through menopause who are at higher risk for dementia to see if it helps them manage their worries and improve their well-being.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 58 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | January 31, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT06965686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 40-58 who are late perimenopausal or early post-menopausal with a family history of dementia.
✕Probably not a fit
Patients with a diagnosis of Mild Cognitive Impairment, Alzheimer's, or other dementia, as well as those with significant cognitive-affecting conditions, will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to develop and pilot test a brief personalized psychosocial intervention called PERI-MIND for middle-aged perimenopausal women who are at elevated risk for dementia. The intervention will address the psychological distress and fears related to dementia that many women experience during the menopause transition. By assessing the intervention's acceptability and feasibility, the study seeks to provide support and coping strategies for this vulnerable population. The focus is on women aged 40-58 who are either late perimenopausal or early post-menopausal and have a family history of dementia.
Why it matters
Potential benefit: If successful, this intervention could help reduce anxiety and improve coping strategies for menopausal women at risk of dementia.
How similar studies have gone: While there is limited data on similar personalized psychosocial interventions specifically for menopausal women at risk of dementia, the approach is innovative and addresses a significant gap in current care.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female sex at birth * Aged between 40-58 years * Late perimenopause or early post-menopause * Elevated dementia risk characterized by first degree relative with diagnosis of Alzheimer's disease or another dementia Exclusion Criteria: * Diagnosis of Mild Cognitive Impairment, Alzheimer's or another dementia * Diagnosis of other chronic illness or condition that affects cognition (e.g., Axis I psychiatric disorders such as schizophrenia or mood disorders, neurological disorders such as stroke, cancer, traumatic brain injury) * Inadequate vision or hearing to engage with intervention materials * Unable or unwilling to provide informed consent * Iatrogenic menopause (i.e., due to surgery)
Where it's running
-
University of Chicago Medicine
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Francesca Farina, PhD — University of Chicago
- Study coordinator: Grace Bardwick, MPH
- Email: griffithlab@bsd.uchicago.edu
- Phone: 773-702-1972
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.