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NCT06965686 · ClinicalTrials.gov registry record · NA
Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk
A NA study of Dementia and Menopausal, sponsored by University of Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06965686: Recruiting NA study of Dementia and Menopausal, sponsored by University of Chicago.
NCT06965686 is a NA study of Dementia and Menopausal that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 60 participants, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06965686, a NA study of Dementia and Menopausal, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
By age 45, women's lifetime risk of dementia is estimated to be 1 in 5. Two-thirds of people currently living with a dementia diagnosis are women, and-women make up the majority of carers for people with dementia. Because women bear a larger burden of the dementia epidemic, they tend to be more fearful about dementia compared to men. Women may be especially fearful during the menopause transition, which can impact cognition. These fears can cause significant psychological distress, functional impairment, and avoidance of help seeking. Interventions that acknowledge women's fears and promote adaptive coping during the menopause transition are needed to combat dementia-related fear and its negative impacts. This project aims to develop, and pilot test a brief personalized, psychosocial intervention for middle-aged perimenopausal individuals with elevated dementia risk. The investigators will assess the intervention's acceptability and feasibility for use in this population. The project will be completed in three stages. First, the investigators will conduct focus groups to better understand individual fears about dementia, informational and decisional needs, and strategies to promote adaptive coping as they transition through menopause (case-only, single time point). Second, the investigators will develop an intervention to meet the specific needs identified by the focus groups. Intervention components will address multiple areas of women's health in midlife, including aspects of physical and psychological health, as well as functional health outcomes that have important and long-lasting life implications. Finally, the investigators will conduct pilot testing to assess the acceptability and feasibility of the intervention (cohort, 3-week testing period). This project will deliver a novel psychosocial intervention that can provide middle-aged perimenopausal women with the information and practical skills that can help them manage their dementia-related fears and enco
Primary Outcome
Feasibility outcomes will relate to the successful implementation and completion of the intervention, including the ease of recruitment and ability of participants to enroll and complete the study. Metrics will include the total number of participants identified and enrolled in the study and completion rate.
Conditions Studied
Interventions
- BEHAVIORAL PERI-MIND
Study Locations (1)
Illinois
- University of Chicago Medicine - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-01-31 |
| Est. Completion | 2026-12-30 |
| Phase | NA |
What NCT06965686 shows while recruiting
NCT06965686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Dementia appearing as the primary indexed condition, and to 1 intervention - of which PERI-MIND is the first listed.
NCT06965686 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06965686 about?
NCT06965686 is a clinical study titled "Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk". By age 45, women's lifetime risk of dementia is estimated to be 1 in 5. Two-thirds of people currently living with a dementia diagnosis are women, and-women make up the majority of carers for people with dementia. Because women bear a larger burden of the dementia epidemic, they tend to be more fear...
What is the current status of trial NCT06965686?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-01-31. Estimated completion is 2026-12-30.
What conditions does trial NCT06965686 study?
This clinical trial studies the following conditions: Dementia, Menopausal.
What interventions are being tested in trial NCT06965686?
The interventions under investigation include: PERI-MIND (BEHAVIORAL).
Who is sponsoring clinical trial NCT06965686?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06965686 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06965686's enrollment target sits among peer trials
60 142nd of 199 higher than 48 of 199 other Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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