Attentional Mechanisms in SCD

NCT06002477 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 230736
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Peak P1 amplitude for Orienting

  Peak P1 amplitude in parietal regions for Orienting trials of the Attention Network Test (ANT) dyrung anticholinergic challenge

  After administration of second drug challenge, approximately 72 hours

Study Arms (2)

Anticholinergic Challenge

EXPERIMENTAL

All participants will receive oral mecamylamine for 1 day

Drug: Mecamylamine Challenge

Placebo Challenge

PLACEBO COMPARATOR

All participants will receive oral placebo for 1 day

Other: Placebo Comparator Challenge

Interventions

Mecamylamine Challenge DRUG

Mecamylamine 20 mg oral pill administered once

Anticholinergic Challenge

Placebo Comparator Challenge OTHER

Matching placebo oral pill administered once

Placebo Challenge

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

Study Officials

• Paul Newhouse, MD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Central Study Contacts

Kimberly Albert, PhD

CONTACT

6159364559; kimberly.albert@vumc.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assitant Professor, Psychiatry

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 21, 2023
• Study Start: March 27, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)