Status:
UNKNOWN
SCI-110 for Alzheimer Disease and Agitation
Lead Sponsor:
The Israeli Medical Center for Alzheimer's
Conditions:
Alzheimer Disease
Eligibility:
All Genders
60-85 years
Phase:
PHASE2
Brief 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 prod...
Eligibility Criteria
Inclusion
- 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
- 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 diagnosed Mental or Psychiatric diseases
- Patients who in the opinion of the investigator are at risk of falling beyond the risk associated with AD (example: postural hypotension, unstable blood pressure, with or without administration of anti-hypertensive medication, α1 blocker drugs used to treat benign prostatic hyperplasia
- Patients diagnosed with epilepsy
Key Trial Info
Start Date :
December 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 29 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05239390
Start Date
December 29 2021
End Date
June 29 2023
Last Update
February 14 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Israeli Medical Center for Alzheimer's
Ramat Gan, Israel, 56621