Alzheimer DiseasePhase 2NCT05239390
SCI-110 for Alzheimer Disease and Agitation
A Phase 2 study testing SCI -110 in people with Alzheimer Disease, run by The Israeli Medical Center for Alzheimer's at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- SCI -110
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Dec 2021to 29 Jun 2023
- Phase
- Phase 2
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Israeli Medical Center for Alzheimer's
Ramat Gan, 56621
Yehoshua Klapper, +972-3-5342221, josh@alzheimer.org.il
Hila Manor, +972-50-8697886, manor483@gmail.com
About this study
Official title: Phase IIA Open-Label, to Evaluate the Safety, Tolerability, and Efficacy Trend of SCI -110 in Patients With AD and Agitation
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.
Read more
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.
- Conditions
- Alzheimer Disease
- Being tested
- SCI -110
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCI -110Drug
Also called Dronabinol and PEA
Dronabinol - Manufactured by Pharmaceutics International, Inc., Hunt Valley, MD 21031, USA. Dronabinol Capsules (dronabinol solution in sesame oil in soft gelatin capsules) are 2.5 mg - cream, oblong, soft-gel capsules. In an NDC 49884-867-02 Bottle of 60 capsules packaged in a well-closed container and stored in a locked refrigerator, 2° to 8°C. Protect from freezing, in accordance with the Israeli legal requirements (Israel Narcotic Drugs Act). Storage conditions should be monitored on a daily basis.
PEA - Manufactured by Pharmacies Inc. 767 Front st. Suite 202. Catasauqua, PA 18032 www.pharmacures.com. 1-888-334-3130. 400 mg PEA tablets, in a 60 mL barrier bottle, 30/400 mm, Bottle of 30 capsules packaged in a well-closed container and stored in RT (20° to 25°C). Storage conditions should be monitored on a daily basis.
| Study group | Role | What they receive |
|---|---|---|
| SCI -110 | Experimental | SCI -110 (Previously known as THX-110): a combination of THC (Doses: 2.5 mg - 12.5 mg per daily dose) and PEA (Dose: 800 mg per daily dose), administered together as separate pills, orally, twice daily (morning and evening - except for the initial titration dose, of 2.5 mg THC+800 mg PEA given once a day, in the morning. Receives: Drug: SCI -110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
drop-out's
Number of drop-out subjects' due to poor tolerability
Measured: up to 64 days
Adverse Events
Number of study treatment (SCI -110) related Adverse Events (AEs) from Baseline (visit 2, day 1) to end of treatment.
Measured: up to 64 days
Secondary outcomes (6)
Change in the Cohen Mansfield Agitation Inventory (CMAI).
Change from Baseline to end of treatment in agitation measured by the Cohen Mansfield Agitation Inventory (CMAI).
Measured: up to 64 days
rescue medication
Frequency of use of rescue medication to control agitation (Frequency of rescue medication use = number of drug administration(s) regardless of dose
Measured: up to 64 days
Change in Mini Mental State Exam (MMSE)
Change from Baseline (visit 2, day 1) to end of treatment in Mini Mental State Exam (MMSE)
Measured: up to 64 days
Change in Sleep Disorders Inventory
Change in quality of sleep from Baseline (visit 2, day 1) to end of treatment measured in Sleep Disorders Inventory
Measured: up to 64 days
Change in The Edinburgh Feeding Evaluation in Dementia Scale
Change in appetite from Baseline (visit 2, day 1) to end of treatment measured in The Edinburgh Feeding Evaluation in Dementia Scale
Measured: up to 64 days
Change in cognitive measures from Baseline (visit 2, day 1) to end of treatment measured in SIB-8 8-item Severe Impairment Battery
Change in SIB-8 8-item Severe Impairment Battery
Measured: up to 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start29 Dec 2021
- Primary completion29 Jun 2023 (estimated)
- Study completion29 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Israeli Medical Center for Alzheimer's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Alexander Kaplan, The Israeli Medical Center for Alzheimer's
- Investigators
- Alexander Kaplan, Principal investigator, The Israeli Medical Center for Alzheimer's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239390
- Sponsor's protocol ID
- NAVE-Sci-001
- Status last verified
- Feb 2022
- First submitted
- 25 Jul 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- 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 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIA Open-Label, to Evaluate the Safety, Tolerability, and Efficacy Trend of SCI -110 in Patients With AD and Agitation
- ClinicalTrials.gov ID
- NCT05239390
- Acronym / sponsor ID
- NAVE-Sci-001
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Israeli Medical Center for Alzheimer'sUniversity, hospital or other
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 29 Jun 2023 (estimated)
- Study completion
- 29 Jun 2023 (estimated)
- First posted
- 14 Feb 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCI -110 | Experimental | Drug: SCI -110SCI -110 (Previously known as THX-110): a combination of THC (Doses: 2.5 mg - 12.5 mg per daily dose) and PEA (Dose: 800 mg per daily dose), administered together as separate pills, orally, twice daily (morning and evening - except for the initial titration dose, of 2.5 mg THC+800 mg PEA given once a day, in the morning. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| SCI -110Also: Dronabinol and PEADronabinol - Manufactured by Pharmaceutics International, Inc., Hunt Valley, MD 21031, USA. Dronabinol Capsules (dronabinol solution in sesame oil in soft gelatin capsules) are 2.5 mg - cream, oblong, soft-gel capsules. In an NDC 49884-867-02 Bottle of 60 capsules packaged in a well-closed container and stored in a locked refrigerator, 2° to 8°C. Protect from freezing, in accordance with the Israeli legal requirements (Israel Narcotic Drugs Act). Storage conditions should be monitored on a daily basis. PEA - Manufactured by Pharmacies Inc. 767 Front st. Suite 202. Catasauqua, PA 18032 www.pharmacures.com. 1-888-334-3130. 400 mg PEA tablets, in a 60 mL barrier bottle, 30/400 mm, Bottle of 30 capsules packaged in a well-closed container and stored in RT (20° to 25°C). Storage conditions should be monitored on a daily basis. | Drug | SCI -110 |
Primary outcome
drop-out's
Time frame: up to 64 days
Number of drop-out subjects' due to poor tolerability
Adverse Events
Time frame: up to 64 days
Number of study treatment (SCI -110) related Adverse Events (AEs) from Baseline (visit 2, day 1) to end of treatment.
6 secondary outcomes
Change in the Cohen Mansfield Agitation Inventory (CMAI).
Time frame: up to 64 days
rescue medication
Time frame: up to 64 days
Change in Mini Mental State Exam (MMSE)
Time frame: up to 64 days
Change in Sleep Disorders Inventory
Time frame: up to 64 days
Change in The Edinburgh Feeding Evaluation in Dementia Scale
Time frame: up to 64 days
Change in cognitive measures from Baseline (visit 2, day 1) to end of treatment measured in SIB-8 8-item Severe Impairment Battery
Time frame: up to 64 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- 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.
Alexander Kaplan principal investigator
The Israeli Medical Center for Alzheimer's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCI -110 in people with Alzheimer Disease, run by The Israeli Medical Center for Alzheimer's at 1 site 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehoshua Klapper (+972-3-5342221, josh@alzheimer.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
drop-out's (time frame: up to 64 days). 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 14 Feb 2022; AzTrials last refreshed its copy on 2 Nov 2026.