Agitation,PsychomotorNCT06217146
A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia.
A study testing Medical Cannabis in people with Agitation,Psychomotor and Disruptive Behavior, run by M. H MediCane Ltd. at 3 sites in Israel.
Trial summary
This double-blind, placebo-controlled study is designed to assess the effectiveness of, MediCane's medical cannabis oil extracted from MediCane's proprietary strain into GMP-grade olive oil, as an add-on therapy to standard of care (SoC), in reducing agitation and disruptive behaviors in subjects with dementia… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Agitation,Psychomotor, Disruptive Behavior, Dementia
- What is being tested?
- Medical Cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesIsrael
- Study dates
- 12 Oct 2022to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are Male or Female age ≥50 years.
- Subjects have a diagnosis of major neurocognitive disorder (previously dementia) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Criteria for at least 6 months prior to screening or a diagnosis of probable AD using the NINCDS-ADRDA clinical criteria.
- Subjects on antipsychotic medications may be included in the study.
- Subject exhibits agitation/aggression with a Neuropsychiatric Inventory (NPI-12)-agitation/aggression subdomain score of four or higher (≥4) at screening.
- Subject has a legal guardian who is able and willing to provide ICF and able to provide - information in writing. The caregiver should be spending enough time with the subject on a regular basis in order to provide valid information as requested.
- Subjects are on stable SoC for treatment of agitation and disruptive behaviors for at least 2 weeks prior to the screening visit.
- Subjects on Acetyl Choline Esterase inhibitors, antifungals, macrolide antibiotics and anti-hypertensive therapy including ACE inhibitors should be on stable doses for at least 2 weeks prior to screening visit or if changed, at least 2 weeks prior to visit 1.
- Subject's Mini Mental State Exam score (MMSE) is 24 or less at screening.
Who cannot join
- Subject without a legal guardian.
- Subject with any current unstable medical condition.
- Subject has any unstable condition involving fluid retention, pulmonary infiltrates, congestive heart failure, respiratory symptoms or disease, or cardiac symptoms or disease.
- Subject has one of the following hepatic /renal disorders:
- Confirmed and unexplained impaired hepatic function as indicated by screening AST or ALT>3 the upper limit of normal (ULN) or total bilirubin > 2 ULN.
- Chronic kidney disease of Stage > 4, according to National Kidney Foundation Kidney Disease Outcome Quality Initiative guidelines for chronic kidney disease.
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- Subject has epilepsy.
- Subject has a history of hypersensitivity to any cannabinoid.
- Subject has the presence or history of a primary psychotic psychiatric disorder or subject has clinically significant delusions or hallucinations secondary to the neurodegenerative disease (NPI-12 delusions or hallucinations sub-score of 4 or higher (≥4).
- Subject suffering from delirium as defined in Appendix B - Criteria for Delirium.
- Current inpatient hospitalization.
- Subject has other health-related factors that could explain behavioral disturbances (electrolyte disturbances, infectious diseases, etc.).
- Subject has a satisfactory response to antipsychotic treatments.
- Subjects treated with one of the following medications: opiates, primidone, phenobarbitol, carbamazepine, rifampicin, rifabutin, troglitazone, hypericum perforatum, or valproic acid within 30 days from Visit 1.
- Subjects currently on medication known to interact with Cannabis-based medications are excluded; Subjects taking Cannabis-based therapies are excluded if within the past 2 weeks from Visit 1.
- Subjects with a history of addiction or drug abuse.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Laniado Hospital
Netanya
Sheba Medical Center
Ramat Gan
Tel-Aviv Sourasky Medical Center Ichilov
Tel Aviv
About this study
Official title: A Two-part Study, Part I an Open-label; and Part II a Randomized Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MediCane's Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia Including Probable Alzheimer's Disease (AD)
This double-blind, placebo-controlled study is designed to assess the effectiveness of, MediCane's medical cannabis oil extracted from MediCane's proprietary strain into GMP-grade olive oil, as an add-on therapy to standard of care (SoC), in reducing agitation and disruptive behaviors in subjects with dementia including probable AD.
- Being tested
- Medical Cannabis, Placebo Oil
- Medical subject headings
- Psychomotor Agitation, Problem Behavior, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical CannabisDrug
MediCane's medical cannabis oil
Placebo OilDrug
Placebo Oil
| Study group | Role | What they receive |
|---|---|---|
| MediCane's medical cannabis oil | Experimental | Not described Receives: Drug: Medical Cannabis |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Safety (Adverse Events)
Number of participants with treatment-related adverse events as assessed by severity. protocol.
Measured: Up to 22 weeks
Part 2 Efficacy (CMAI)
Change in agitation and aggression from baseline to Week 12 as measured using the Cohen-Mansfield Agitation Inventory-Community (CMAI-C), a 37-item scale that measures the types and frequencies of agitated behaviors, each rated on a 7-point scale of frequency, where higher scores indicate greater agitation severity.
Measured: 12 weeks
Secondary outcomes (1)
Part 1 Efficacy (NPI-12)
Change in neuropsychiatric symptoms measured by the total score and subscores of the NPI-12.
Measured: up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start12 Oct 2022
- Primary completion10 Mar 2024
- Study completion10 Mar 2024
Why it stopped: Part I: Open-label was completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation,PsychomotorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- M. H MediCane Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neta Rimmerman, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217146
- Sponsor's protocol ID
- AGM-01
- Status last verified
- Jun 2024
- First submitted
- 20 Nov 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Study, Part I an Open-label; and Part II a Randomized Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MediCane's Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia Including Probable Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT06217146
- Acronym / sponsor ID
- AGM-01
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part I: Open-label was completed.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- M. H MediCane Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blind, placebo-controlled study is designed to assess the effectiveness of, MediCane's medical cannabis oil extracted from MediCane's proprietary strain into GMP-grade olive oil, as an add-on therapy to standard of care (SoC), in reducing agitation and disruptive behaviors in subjects with dementia including probable AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MediCane's medical cannabis oil | Experimental | Drug: Medical Cannabis |
| Placebo | Placebo comparator | Drug: Placebo Oil |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects are Male or Female age ≥50 years.
- Subjects have a diagnosis of major neurocognitive disorder (previously dementia) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Criteria for at least 6 months prior to screening or a diagnosis of probable AD using the NINCDS-ADRDA clinical criteria.
- Subjects on antipsychotic medications may be included in the study.
- Subject exhibits agitation/aggression with a Neuropsychiatric Inventory (NPI-12)-agitation/aggression subdomain score of four or higher (≥4) at screening.
- Subject has a legal guardian who is able and willing to provide ICF and able to provide - information in writing. The caregiver should be spending enough time with the subject on a regular basis in order to provide valid information as requested.
Key exclusion criteria (16 listed)
- Subject without a legal guardian.
- Subject with any current unstable medical condition.
- Subject has any unstable condition involving fluid retention, pulmonary infiltrates, congestive heart failure, respiratory symptoms or disease, or cardiac symptoms or disease.
- Subject has one of the following hepatic /renal disorders:
- Subject has epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical CannabisMediCane's medical cannabis oil | Drug | MediCane's medical cannabis oil |
| Placebo OilPlacebo Oil | Drug | Placebo |
Primary outcome
Part 1 Safety (Adverse Events)
Time frame: Up to 22 weeks
Number of participants with treatment-related adverse events as assessed by severity. protocol.
Part 2 Efficacy (CMAI)
Time frame: 12 weeks
Change in agitation and aggression from baseline to Week 12 as measured using the Cohen-Mansfield Agitation Inventory-Community (CMAI-C), a 37-item scale that measures the types and frequencies of agitated behaviors, each rated on a 7-point scale of frequency, where higher scores indicate greater agitation severity.
1 secondary outcome
Part 1 Efficacy (NPI-12)
Time frame: up to 18 weeks
Results and safety
The study was stopped early (reason given: Part I: Open-label was completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neta Rimmerman, PhD study director
Sponsor GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Cannabis in people with Agitation,Psychomotor and Disruptive Behavior, run by M. H MediCane Ltd. at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Part I: Open-label was completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 Safety (Adverse Events) (time frame: Up to 22 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.