Nicotine Treatment of Cognitive Decline in Down Syndrome

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The knowledge gained from the translational aspects of this project may also guide the application of new nicotinic drugs in DS and generate, for the first time, data on the importance of nicotinic receptor changes in the development of cognitive impairment in DS adults.

It had 1 arm (groups): Nicotine (experimental).

The registry classes the interventions as drug.

More on the Plan

Thus, age-associated cognitive impairment and dementia in older adults with DS is an urgent public health concern.

The investigators have extensive experience investigating the role of nicotinic receptors on human cognition and impairment.

The goal of this study is to establish preliminary evidence for safety, gain preliminary evidence as to whether nicotine enhances cognitive functioning in DS adults, and examine electrophysiological, biological, and behavioral correlates of nicotinic stimulation effects.

The investigators propose that positive results on cognitive or functional indices that would lead to a larger and longer double-blind trial to test more definitively whether nicotinic stimulation may be cognitively and/or functionally enhancing for DS patients.

Who Took Part

7 actual participants took part.

It was open to people of any sex aged from 25 years with no upper age limit.

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

Examples of who could join: Cognitive complaints and/or memory difficulties which are verified as new onset by an informant. Cognitive Global Rating consistent with mild impairment or deterioration from premorbid baseline. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease/dementia cannot be made by the physician at the time of the screening visit. Stable medications for at least 1 month prior to screening. Central nervous system (CNS) medications should be stable for 3 months. No evidence of major depression.

The full record lists 16 inclusion and 11 exclusion criteria; among the exclusions: active major depression or another major psychiatric disorder as described in dsm-iv; history of alcohol or substance abuse or dependence within the past 2 years (dsm iv criteria); history of myocardial infarction in the past year or unstable or severe cardiovascular disease including angina or congestive heart failure (chf) with symptoms at rest.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-04 with completion listed for 2021-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Tolerability of Nicotine Intervention (time frame: 1 Month).

It also tracked 5 secondary outcomes, for example Exploratory - Event-Related Potentials.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Therapeutic nicotine (patch, non-peptide) in 7 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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