Cholinergic Health After Menopause (CHAMP)

What this trial studies

Women are at increased risk for Alzheimer's disease (AD). Notably at menopause, some women experience a change in cognition. However, not all women experience negative effects of menopause on cognition. The cognitive changes that occur at menopause have not yet been connected to late life risk for pathological aging including AD.

Conditions in scope

• Postmenopausal Symptoms
• Aging
• Alzheimer Disease

Interventions

• Cholinergic antagonist (Drug) — The cholinergic antagonist drug mecamylamine will be administered as a a 20 mg oral pill and matching placebo

Who can join

Women only · Ages 50 Years to 70 Years · Accepts healthy volunteers.

Inclusion criteria

• Women aged 50-70 years
• Postmenopausal
• Nonsmokers
• Not taking hormone therapy, selective serotonin uptake inhibitors (SSRIs(, phytoestrogens, selective estrogen receptor modulators (SERMS), or antiestrogen medications and will be at least one year without such treatment
• Physically healthy
• No cardiovascular disease other than mild hypertension. Subjects will also not have current untreated or unremitted Axis I or II psychiatric or cognitive disorders (see screening below).
• Intelligence quotient (IQ) in the normal range \>80
• Normal neuropsychological test performance

Exclusion criteria

• Mild Cognitive Impairment (MCI) or dementia - Montreal Cognitive Assessment \<26, Mattis Dementia Rating Scale \<130, and Global Deterioration Scale \>2
• History of cancer treatment with cytotoxic and/or ongoing (current) maintenance targeted chemotherapy
• Blood pressure \> 160/100 (untreated)
• Untreated thyroid disease
• Significant cardiovascular disease
• Asthma or chronic obstructive pulmonary disease (COPD)
• Active peptic ulcer
• Hyperthyroidism

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: Completed
• Study type: Interventional
• Phase: EARLY_PHASE1
• Start date: 2020-03-15
• Primary completion: 2024-12-16
• Last update posted: 2025-12-16
• First posted: 2019-10-16

Sponsor & contact

Lead sponsor: University of Vermont (Other)

Collaborators: Vanderbilt University Medical Center

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

• Blood Oxygen Dependent (BOLD) functional magnetic resonance imaging (fMRI) (Two hours post drug administration)
  BOLD fMRI signal will be measured while each participant performs the N-back test.
• Working Memory Performance (Two hours post drug administration)
  We will assess performance on the N-back test of working memory test.
• Basal Forebrain Cholinergic System Volume (Two hours post drug administration)
  We will measure basal forebrain cholinergic system volume from the T1 images acquired during the MRI scan.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.