PERI-MIND for Menopause and Dementia Risk

(PERI-MIND Trial)

Overseen By Grace Bardwick, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Mild cognitive impairment, Alzheimer's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called PERI-MIND, aimed at helping middle-aged women in menopause who worry about dementia. The goal is to determine if this program can reduce fear and improve coping skills related to dementia risks. Participants will first join focus groups to share their concerns and then test an online intervention designed from those discussions. Women in late perimenopause or early post-menopause, with a family history of dementia, may be well-suited for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new methods for managing dementia-related concerns.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this psychosocial intervention is safe for perimenopausal individuals?

Research has shown that the PERI-MIND program is still under study, so specific safety information is not yet available. However, since this program emphasizes mental and emotional support, the risks are generally lower than those associated with medical treatments. The program aims to help women manage fears about dementia during menopause by focusing on mental and emotional health, rather than medication or physical procedures. Therefore, it is likely to be well-tolerated. Participants will be closely monitored to ensure their safety and comfort throughout the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PERI-MIND because it offers a fresh approach to addressing menopause and dementia risk. Unlike traditional hormone replacement therapies that primarily focus on alleviating menopausal symptoms, PERI-MIND seeks to understand and address the cognitive fears and needs of perimenopausal individuals with a family history of dementia through interactive online interventions. By focusing on informational and decisional needs and promoting adaptive coping strategies, this approach could provide a more personalized and psychologically supportive way to navigate menopause and potentially reduce dementia risk.

What evidence suggests that this psychosocial intervention is effective for managing dementia-related fears during menopause?

Research has shown that menopause might increase the risk of developing dementia later in life, which is particularly concerning for women already at higher risk. The PERI-MIND project, which participants in this trial will engage with, is developing a program to help middle-aged women manage their worries about dementia during menopause. Although data on the effectiveness of PERI-MIND is still limited, the project aims to teach practical skills for coping and reducing stress. Early signs suggest that addressing these fears can benefit mental health in this group. ^{1 2 6 7 8}

Who Is on the Research Team?

Francesca Farina, PhD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for middle-aged perimenopausal individuals who are at an increased risk of developing dementia. It aims to help them manage fears related to dementia and improve their coping during the menopause transition. The eligibility criteria details were not provided, so specific inclusions or exclusions cannot be listed.

Inclusion Criteria

I am between 40 and 58 years old.

I have a high risk of dementia due to a family history.

I was born female.

Exclusion Criteria

Inadequate vision or hearing to engage with intervention materials

I have been diagnosed with Mild Cognitive Impairment, Alzheimer's, or another form of dementia.

Unable or unwilling to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Groups

Participants take part in a single 1-hour remote focus group session to discuss fears about dementia and strategies for adaptive coping

1 session

1 visit (virtual)

Intervention Development

Development of a personalized intervention based on focus group findings

Not specified

Pilot Testing

Participants evaluate the online intervention materials over a 3-week period focusing on feasibility and acceptability

3 weeks

Follow-up

Participants are monitored for feedback on the intervention's effectiveness and any long-term impacts

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PERI-MIND

Trial Overview The PERI-MIND intervention is being tested, which is a personalized psychosocial program designed to address women's health issues during midlife. This includes physical, psychological, and functional health aspects with the goal of reducing fear and promoting adaptive coping strategies.

How Is the Trial Designed?

Group I: Perimenopausal individuals with a family history of dementia Experimental Treatment 1 Intervention

For the focus groups, the investigators will recruit a minimum of 20 participants. Participants will take part in a single 1-hour remote focus group session, where they will be asked about their fears about dementia, informational and decisional needs, and strategies to promote adaptive coping as they transition through menopause. For pilot testing, we will recruit a minimum of 30 participants. Participants will be asked to evaluate the online intervention materials across 3-weeks. The evaluation will focus on feasibility and acceptability of the intervention.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. obgyn.uchicago.edu obgyn.uchicago.edu/research/peri-mind

PERI-MIND PERI-MIND project aims to learn more about the experiences of people going through menopause who are at higher risk of dementia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8394691/

Menopause and cognitive impairment: A narrative review of ... The authors concluded that HT with the combination of estrogen and progestogen increased the risk of probable dementia in postmenopausal women aged 65 years ...

3. withpower.com withpower.com/trial/phase-dementia-2025-595f1

PERI-MIND for Menopause and Dementia Risk This trial is for middle-aged perimenopausal individuals who are at an increased risk of developing dementia. It aims to help them manage fears related to ...

4. nytimes.com nytimes.com/2023/11/21/well/mind/menopause-dementia-risk-estrogen.html

How Menopause Changes the Brain There is growing consensus that menopause may also be an important risk factor for the development of dementia later in life.

5. menopause.org.au menopause.org.au/hp/information-sheets/oestrogen-and-cognition-in-the-perimenopause-and-menopause

Oestrogen and cognition in the perimenopause and ... Observational studies indicate an increased risk of memory deficits and Alzheimer's disease associated with premature surgical oophorectomy.

6. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00210-9/fulltext

Association of earlier age at menopause with risk ... Earlier age at menopause was associated with risk of incident dementia and deteriorating brain health. Further studies are warranted to clarify ...

7. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.092052

Cognitive and behavioral decline predicted by ... The experience of brain fog, weight changes, and mood changes during perimenopause may predict greater risk for cognitive and behavioral changes ...

8. bmj.com bmj.com/content/381/bmj-2022-072770

Menopausal hormone therapy and dementia: nationwide ... Menopausal hormone therapy was positively associated with development of all cause dementia and Alzheimer's disease, even in women who received treatment at ...