Information about the intervention that will be tested in the study
Non-invasive transcutaneous electrical stimulation procedure (electrodes will be placed on the scalp)
Is the intervention on the market for another medical condition?
Will all participants receive the same intervention?
Participants will be selected at random to either receive one of the following options:
- An active stimulation of NITESGON on the scalp
- An inactive stimulation on the scalp (also called an inactive control) to mimic the NITESGON stimulation without producing any conditioning effects on the brain
- An active stimulation of NITESGON on the scalp in combination with a skin anesthetic (lidocaine/prilocaine cream) to reduce any potential contribution from transcutaneous stimulation of peripheral nerves
- An active stimulation in the cervical nerves (also called an active control) to mimic the sensation in another location.
Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the effectiveness of NITESGON in decreasing a long-term forgetting in people with amnestic mild cognitive impairment.
How long will the intervention last?
A unique stimulation
What your involvement will entail?
- During the study, participants will be asked to complete a memory recall test immediately after the stimulation, and 7 and 28 days after simulation. Participants will be asked to learn a list of 50 Swahili-English word pairs. Then, they will be presented with the Swahili word and asked to type the correct English translation
- To do electroencephalogram (EEG), a test that measure electrical activity in the brain, to determine neurophysiological changes immediately before and after stimulation.
Further information can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be 55 years and older
- Have a diagnosis of probable amnestic mild cognitive impairment or mild Alzheimer’s disease
- Have a score between 18 and 25 in the Montreal Cognitive Assessment (a cognitive screening test). This would suggest that the person has an impairment in a mild stage
- Have a score above 21 in the MMSE questionnaire (a test about your memory). This would suggest that the person has an impairment in their memory that is at a mild stage
- If the person is taking approved symptomatic medication for dementia (i.e. donepezil, rivastigmine, galantamine) the dosing regimen must have been stable for at least 3 months
- Have an adequate visual and auditory acuity.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Any diagnosis of cognitive decline or dementia other than related to Alzheimer's disease such as vascular dementia, frontotemporal dementia, Parkinson's disease, Dementia with Lewy Bodies
- Enrolment in an ongoing investigational medicinal product study
- History of epileptic seizures in the past 2 years
- A disease or medical condition that may interfere with the study assessments and will make the participant unsuitable for participation in or completion of the trial procedures (i.e. psychiatric disorder, trauma, stroke, intellectual disability)
- Any alcohol or drug abuse within the last 12 months
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
Study contact information
Sven Vanneste +35318968521
Katherine S Adcock +3530864589155
Link to full text
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on December 2022.
This document has been reviewed by the pharmaceutical company running this trial.
This document has been reviewed by a member of the European Working Group of People with Dementia.