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Search / Trial NCT07021664

Health, Imaging, and Cognition Across the Menopausal Transition

Launched by UNIVERSITÉ DE SHERBROOKE · Jun 12, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Menopause Cognition Metabolism Estrogen Ketone Pet Scan Estrogen Receptor

ClinConnect Summary

This clinical trial, titled "Health, Imaging, and Cognition Across the Menopausal Transition," is studying how menopause affects brain energy use and thinking abilities. Menopause is a normal part of aging for women, marked by changes in hormone levels that can lead to symptoms like hot flashes, mood swings, and memory issues. Researchers believe that as estrogen levels decline during menopause, the brain may not use glucose (its main energy source) as effectively, which might contribute to these cognitive problems. They will also explore how using ketones, an alternative energy source, could help support brain function during this time.

The study will involve 45 women aged 35 to 60, divided into three groups based on their menopausal stage: premenopause, perimenopause, and postmenopause. To participate, women must be able to read and speak French and meet specific age and menstrual cycle criteria. Participants can expect to attend four study visits that include questionnaires, blood tests, cognitive tests, and advanced brain imaging. This research aims to better understand how hormonal changes impact brain health, which could lead to new ways to support cognitive function in aging women.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Able to read and speak French
  • Capable of understanding and signing informed consent GROUP SPECIFIC INCLUSION CRITERIA Premenopause: • Women aged 35 to 55; No change in menstrual cycle regularity over the past 10 months (variation less than 7 days per cycle)
  • Perimenopause: Women aged 40 to 60; Menstrual cycles varying by more than 7 days per cycle for at least 10 cycles, or no period for 3 to 11 months
  • postmenopause: Women aged 45 to 65; No menstrual period for ≥ 12 months
  • Exclusion Criteria:
  • Pregnancy, childbirth within the past 12 months, or breastfeeding
  • Use of hormone replacement therapy or hormonal contraceptives in the past 6 months
  • contraindications to MRI (e.g., presence of non-compatible metallic objects)
  • Claustrophobia
  • Type 1 diabetes
  • Adherence to a ketogenic intervention (e.g., ketone supplements, intermittent fasting, ketogenic diet) in the past 3 months
  • Engaging in intense physical activity 5 times per week or more
  • Any significant neurological disorder (e.g., dementia, brain tumor, seizure disorder, history of significant head trauma with persistent neurological deficits, known structural brain abnormalities)
  • History of oophorectomy or hysterectomy
  • Any significant psychiatric disorder (e.g., major depression within the past 2 years, bipolar disorder, schizophrenia)
  • Systemic diseases or unstable/uncontrolled medical conditions (e.g., cardiovascular disease, uncontrolled diabetes, kidney or liver disorders)
  • Any other condition that may interfere with participation, as judged by the study physician

About Université De Sherbrooke

The Université de Sherbrooke is a leading research institution in Canada, renowned for its commitment to advancing knowledge and innovation in various fields, including health sciences. With a focus on interdisciplinary collaboration, the university actively engages in clinical trials to explore new therapeutic interventions and improve patient care. Its research team comprises experienced professionals dedicated to ensuring the highest ethical standards and scientific rigor in clinical research. The Université de Sherbrooke strives to translate research findings into practical solutions that enhance health outcomes and contribute to the advancement of medical science.

Locations

Sherbrooke, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Stephen Cunnane, Ph.D

Principal Investigator

Université de Sherbrooke

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported