Nicotine Treatment of Mild Cognitive Impairment (MCI)

What Was Tested

The trial (phase 1) is built around Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Placebo Group (placebo comparator) and Active Nicotine Group (experimental).

Placebo for first six months of study; moved to open-label active nicotine for second six months.

Blinded active nicotine for first six months of study; open-label active nicotine for second six months.

The registry classes the interventions as drug.

More on the Plan

The study will last approximately 12 months and will be conducted at 3 clinical sites in the United States.

This chemical substance, acetylcholine, is thought to act on certain brain cells in a specific way that helps them to remember and use memories as well as affect their mood.

In MCI (and Alzheimer's disease), the level of acetylcholine may be changed, and this may impair brain functioning.

Nicotine imitates many of the actions of acetylcholine.

Who Took Part

The registry lists 75 planned participants were the target.

It was open to people of any sex aged from 55 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Memory complaints and memory difficulties which are verified by an informant. Less than or equal to 8 for 16 or more years of education,. Less than or equal to 4 for 8 - 15 years of education,. Less than or equal to 2 for 0 - 7 years of education. Mini-Mental Status Exam score between 24 and 30 (inclusive).

The full record lists 18 inclusion and 6 exclusion criteria; among the exclusions: major depression or another major psychiatric disorder as described in dsm-iv within the past 2 years; history of alcohol or substance abuse or dependence within the past 2 years (dsm iv criteria); use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Therapeutic nicotine (patch, non-peptide) and the comparison in turn, acting as their own control.

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, care provider, investigator and outcomes assessor.

It started in 2003-09 with completion listed for 2008-07.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Safety of transdermal nicotine patch (time frame: 13 months).

It also tracked 2 secondary outcomes, for example Change in cognitive performance and Change in global functioning.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 75 people.

Its status is unknown; 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.