Personalized intervention for menopausal women at risk of dementia
Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 58 Years |
| Sex | Female |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06965686 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 40-58 who are late perimenopausal or early post-menopausal with a family history of dementia.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.