SCI-110 for Alzheimer’s disease and agitation
Information about the drug that will be tested in the study
Administration
A pill taken orally twice a day (morning and evening)
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
All participants will receive a pill of SCI-110.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the safety, tolerability, and efficacy of SCI -110 in people with Alzheimer's disease and agitation.
How long will the treatment last?
Up to 64 days
What your involvement will entail?
- During the study, participants will be asked to complete some laboratory/biological tests to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
- Complete a test that will assess thinking skills, behaviour, function (this is a test called MMSE)
- Complete tests that will assess their agitation and sleep quality (i.e. tests like CMAI, SDI).
Further information on the procedures, tests and number of visits 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 between 60 and 85 years old
- Have a diagnosis of possible and probable Alzheimer’s disease according to the NINCDS criteria
- Have a score less than 24 in the MMSE test (a test about your memory). This would suggest that the person has an impairment in their memory
- Need medication to control agitation or whose current anti-agitation medication is ineffective or poorly tolerated
- Take stable dose medications for at least 1 week.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Participation in other clinical studies within the past 30 days
- A disease or conditions that may interfere with the safety, tolerability and/or study assessments, or put the participant at special risk (e.g. psychiatric symptoms, auto-immune disease, inflammatory neurological disorders, epilepsy)
- Agitation that can be attributed to a somatic disorder (e.g. urinary tract infection or urinary retention)
- Ongoing medications including opiates, primidone, Phenobarbitol, carbamazepine, Rifampicin, Rifabutin, Troglitazone and Hypericum perforatum
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
Clinicaltrials.gov identifier
NCT05239390
Study contact information
Link to full text
https://clinicaltrials.gov/ct2/show/NCT05239390
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on March 2022.
