--- title: Health, Imaging, and Cognition Across the Menopausal Transition nct_id: NCT07021664 overall_status: NOT_YET_RECRUITING sponsor: Université de Sherbrooke study_type: OBSERVATIONAL primary_condition: Menopause countries: Canada canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07021664.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07021664" ct_last_update_post_date: 2025-06-15 last_seen_at: "2026-05-12T07:23:15.084Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Health, Imaging, and Cognition Across the Menopausal Transition **Official Title:** Santé, Imagerie et Cognition à Travers la Transition ménopausique **NCT ID:** [NCT07021664](https://clinicaltrials.gov/study/NCT07021664) ## Key Facts - **Status:** NOT_YET_RECRUITING - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 45 - **Lead Sponsor:** Université de Sherbrooke - **Collaborators:** Nestlé Health Science - **Conditions:** Menopause - **Start Date:** 2025-07-01 - **Completion Date:** 2026-07-01 - **CT.gov Last Update:** 2025-06-15 ## Brief Summary This observational cross-sectional study aims to better understand how the menopausal transition affects brain energy metabolism and cognition. Menopause, a natural stage in a woman's life, is typically divided into three phases: premenopause, perimenopause, and postmenopause. This transition involves hormonal fluctuations and a decline in estrogen levels, which can impact physical, emotional, and cognitive well-being. Common symptoms include hot flashes, sleep disturbances, mood changes, and difficulties with memory and concentration. Emerging evidence suggests that the decline in estrogen may impair how the brain uses glucose, its primary energy source. This reduction in glucose metabolism is thought to contribute to cognitive difficulties reported during midlife. In contrast, the brain's capacity to use ketones-alternative energy substrates produced during fasting or low-carbohydrate intake-appears preserved during aging and hormonal changes. Increasing circulating ketones may offer a promising strategy to support brain energy and cognitive function. To explore these relationships, the study will employ advanced brain imaging (PET scans) to assess glucose and ketone uptake in the brain. Additional measures will include hormone levels, cognitive testing, continuous glucose monitoring, and MRI. PET tracers will also be used to evaluate estrogen receptor distribution, providing insight into how the brain responds to hormonal changes. A total of 45 women aged 35-60 will be enrolled and categorized into three groups (15 per group): premenopause, perimenopause, and postmenopause. Each participant will attend four study visits that include questionnaires, blood tests, cognitive assessments, metabolic measurements, and imaging procedures. The results may help identify early neurobiological and metabolic markers associated with the menopausal transition. These findings could inform new approaches to preserve brain health and prevent cognitive decline in aging women. Improving understanding of how the female brain adapts to hormonal shifts may ultimately support more targeted strategies for promoting healthy aging. ## Eligibility - **Minimum age:** 35 Years - **Maximum age:** 65 Years - **Sex:** FEMALE - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **premenopause** — Women between 35 and 55 years old who still have regular menstrual cycles, with no noticeable changes in the past 10 months. - **perimenopause** — Women between 40 and 60 years old who have experienced changes in their menstrual cycles, such as irregular timing (varying by more than 7 days) for at least 10 cycles, or no period for 3 to 11 months. - **postmenopause** — Women between 45 and 65 years old who have not had a menstrual period for 12 months or more. ## Primary Outcomes - **cerebral metabolic rates (μmol/100 g/min) measured by PET (11C-AcAc +18F-FDG)** _(time frame: 1 day at baseline)_ — Brain energy metabolism will be quantified using two PET tracers: 11C-acetoacetate (for ketone use) and 18F-fluorodeoxyglucose (for glucose use). This will allow comparison of brain fuel usage between three menopausal groups (PRE, PERI, POST).Total Cerebral metabolic rates (μmol/100 g/min) (CMR tot= CMR acac + CMRglu) - **Tracer influx rates (k) measured by PET (11C-AcAc +18F-FDG)** _(time frame: 1 day at baseline)_ — Brain energy metabolism will be quantified using two PET tracers: 11C-acetoacetate (for ketone use) and 18F-fluorodeoxyglucose (for glucose use). This will allow comparison of brain fuel usage between three menopausal groups (PRE, PERI, POST). tracer influx rates (K values). ## Secondary Outcomes - **Time-activity curves of the estrogen receptor in the brain (by 18F-4FMFES PET)** _(time frame: 1 day at baseline)_ - **distribution volume ratio of the estrogen receptor in the brain (by 18F-4FMFES PET)** _(time frame: 1 day at baseline)_ - **Glucose variability (SD of glucose measured by continuous glucose monitoring)** _(time frame: Over 5 days following sensor placement et stabilisation)_ - **Glucose average (mean of glucose measured by continuous glucose monitoring)** _(time frame: Over 5 days following sensor placement et stabilisation)_ - **Time in range** _(time frame: Over 5 days following sensor placement et stabilisation)_ ## Locations (1) - Centre de recherche sur le Vieillissement, Sherbrooke, Quebec, Canada ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.centre de recherche sur le vieillissement|sherbrooke|quebec|canada` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07021664.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07021664* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*