Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk

What this trial studies

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.

Conditions in scope

• Menopausal
• Dementia

Interventions

• PERI-MIND (Behavioral) — PERI-MIND will be informed by the focus group findings from phase one. However, the investigators anticipate including core components related to psychoeducation, psychological grounding, \& behavioral activation, which will be specifically adapted to the perimenopausal and menopausal population. Psychoeducation in…

Who can join

Women only · Ages 40 Years to 58 Years

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)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-01-31
• Primary completion: 2026-12-30
• Last update posted: 2026-02-05
• First posted: 2025-05-11

Sponsor & contact

Lead sponsor: University of Chicago (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Number of participants who are enrolled and complete the study (From enrollment until pilot testing is completed)
  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.
• Acceptability of intervention content (From enrollment until pilot testing is completed)
  Acceptability will be assessed using standard Likert-type scales, informed by the Theoretical Framework of Acceptability for healthcare interventions. Questions will focus on the content, presentation format and length.

Related ClearedRx care

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