Recruiting
Early Phase 1

Anticholinergic Probe

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06002477

Conditions

Subjective Cognitive Decline

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Mecamylamine Challenge

Placebo Comparator Challenge

Study Details

Brief summary:

This study will use an anticholinergic pharmacological probe to examine attention network function in SCD using EEG. The overall hypothesis is that in older adults with SCD, normal cognitive performance is maintained by compensatory attention network activity, supported by enhanced cholinergic function. The investigators anticipate that SCD will be associated with greater compensatory attention network activity and that disrupting this compensatory process through anticholinergic challenge will result in a greater negative effect on attentional performance (Attention Network Test, ANT) and attention network functioning (EEG) in older adults with greater subjective cognitive concern.

Conditions

Subjective Cognitive Decline

Study ID

NCT06002477

Start date

Jun 6, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. age ≥ 55
2. Montreal Cognitive Assessment (MoCA) > 25 AND Global Deterioration Scale (GDS) rating < 3
3. Non-smokers

Exclusion Criteria:

1. medical contraindications to the drug challenge
2. primary neurological disorder (such as stroke, epilepsy, etc.)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Anticholinergic Challenge

All participants will receive oral mecamylamine for 1 day

placebo comparator: Placebo Challenge

All participants will receive oral placebo for 1 day

Interventions

Mecamylamine Challenge

Mecamylamine 20 mg oral pill administered once

Placebo Comparator Challenge

Matching placebo oral pill administered once

Primary outcome measure

  • Peak P1 amplitude for Orienting [ Time Frame: After administration of second drug challenge, approximately 72 hours ]

Central Contacts and Locations

Central contacts

Kimberly Albert, PhD

6159364559kimberly.albert@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-06-04.