Clinical trial

Cholinergic Mechanisms of Attention in Aging

Name

210003

Description

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 SCD compared to those without SCD.

Trial arms

Trial start

2022-04-21

Estimated PCD

2024-05-30

Trial end

2024-05-30

Status

Recruiting

Phase

Early phase I

Treatment

Mecamylamine Challenge

Mecamylamine 20 mg oral pill administered once

Arms:

Anticholinergic Challenge

Placebo Comparator Challenge

Matching placebo oral pill administered once

Arms:

Placebo Challenge

Size

Primary endpoint

Proportion of participants who complete study visits with drug challenge

After administration of second drug challenge, approximately 72 hours

Proportion of participants who complete EEG

After administration of second drug challenge, approximately 72 hours

Eligibility criteria

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.)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2023-12-28

1 organization

1 product

1 indication

Organization

Vanderbilt University Medical Center

Product

Mecamylamine

Indication

Subjective Cognitive Decline