The Nicotinic Cholinergic System and Cognitive Aging

What Was Tested

In this phase 1 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

This is critical because the ever growing healthy aging population will show declines in cognition that fall short of dementia but still impact functional abilities and independence.

It had two arms (groups): Older Adults (experimental) and Younger Adults (experimental).

Healthy adults aged 65-75 will participate in three study days where they are randomly assigned to receive either nicotine patch, oral mecamylamine, placebo and perform a working memory task during the fMRI. BOLD signal is the outcome measure.

Healthy adults aged 18-30 will participate in three study days where they are randomly assigned to receive either nicotine patch, oral mecamylamine, or placebo and perform a working memory task during the fMRI.BOLD signal is the outcome measure.

The registry classes the interventions as drug.

More on the Plan

This is critical because the expansion of the healthy aging population will nonetheless show declines in cognition that fall short of dementia but still impact functional abilities and independence.

Understanding the effects of age-related functional changes on the nicotinic system will elucidate one neurochemical mechanism underlying age-related changes in cognition and will provide information about how nicotinic dysfunction affects cognition in healthy older adults.

The investigators propose that nicotinic system changes are responsible for age differences in working memory task performance and brain activation.

The investigators can observe the functioning of the nicotinic system by examining brain activation patterns in response to nicotinic blockade and stimulation.

Who Took Part

Enrollment: 104 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Normal cognition, not demented, no mild cognitive impairment. IQ greater than 80.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: current use of barbiturates, rifampin, insulin, carbamezepine, oral hypoglycemics, antidepressants, diabetes, or untreated thyroid disease.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2016-10-01 with completion listed for 2021-12-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Age effects of nicotinic blockade (time frame: After the completion of the third study day). Age effects of nicotinic stimulation (time frame: After the completion of the third study day).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 104 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.