SCI-110 for Alzheimer Disease and Agitation (NCT05239390) | Clinical Trial Compass
UnknownPhase 2
SCI-110 for Alzheimer Disease and Agitation
Israel20 participantsStarted 2021-12-29
Plain-language summary
As of today, there is no FDA-approved treatment for agitation in AD. Hence, it is still considered an unmet need.
Sporadic observation in healthy or diagnosed individuals indicated that cannabis products, in particular, THC have calming and anti-anxiety effects. These observations are supported by basic science data as well as animal experiments.
SCI -110 is a combination of (1) dronabinol, the active ingredient in an FDA-approved synthetic analog of tetrahydrocannabinol, the psychoactive molecule in the cannabis plant, and (2) palmitoylethanolamide.
In the present study, the starting daily dose for all subjects is 2.5 mg dronabinol and 800 mg PEA and will be gradually increased (every 3 days an addition of 2.5 mg dronabinol per day, with no change in the PEA dose) to a maximum of 12.5 mg Dronebinol and 800 mg PEA per day. The study product will be given orally, twice daily, to add-on the medical treatment.
Study Duration per patient is up to 64 days: a. screening (3-21 days); b. treatment phase: (1) titration (15-23 days) of dronabinol from 2.5 to 12.5 mg or up to the maximal subject's tolerated dose (2) Stabilization phase (10 days) until end of treatment on the highest subject's daily tolerated dose. c. follow-up phase (7 days) - until the end-of-study.
During the study, the tolerability of the drug, its safety (vital signs, physical examinations, blood, and urine tests and side effects follow-up) as well as changes in subject's condition (using CMAI, MMSE, SIB-8 questionnaires), appetite and sleep quality (SDI) will be followed.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female aged \>60 to \<85 years inclusive.
* Patients diagnosed according to the NINCDS criteria for AD (possible and probable).
* MMSE less than 24 at the time of screening.
* Patients who in the opinion of the investigators need medication to control agitation or whose current anti-agitation medication is ineffective or poorly tolerated
* Patients who have been taking stable dose concomitant medications for at least 1 week.
* Only individuals who have a legally appointed guardian who can sign Informed Consent Form (ICF)
Exclusion Criteria:
* Participant in other clinical trial during the last 30 days.
* Any disorder which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol.
* Patients whose agitation can be attributed to a somatic disorder (Ex. urinary tract infection or urinary retention)
* Patient with uncontrolled congestive heart failure.
* Patients who get the following medications: opiates, Primidone, Phenobarbitol, carbamazepine, Rifampicin, Rifabutin, Troglitazone and Hypericum perforatum.
* Male patients who in the opinion of the investigator are at risk of urinary retention due to the anticholinergic proprieties of THC
* Subjects with known sensitivity to the active substance dronabinol or to any of the components of the drug (sesame oil, gelatin, glycerol, titanium dioxide
* Subjects that previously suffered from cannabinoids' related adverse effects.
* Subjects with a history of diagnose…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.