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UnknownPhase 2

SCI-110 for Alzheimer Disease and Agitation

Phase IIA Open-Label, to Evaluate the Safety, Tolerability, and Efficacy Trend of SCI -110 in Patients With AD and Agitation

Asset

SCI -110

Listed sites

1

Recruiting sites

1

Enrollment

20

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age 60-85

Primary endpoints

•Drop-out's•Adverse Events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDNAVE-Sci-001
NCT IDNCT05239390

Timeline

Milestones

Study start2021-12-29actual
Study first posted2022-02-14actual
Last update posted2022-02-14actual
Primary completion2023-06-29estimated
Study completion2023-06-29estimated

Assets

Drug assets

SCI -110

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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 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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
3
Global cognition
2
Safety / tolerability / PK
2
Other (unclassified)
1

Global cognition

2 endpoints
Secondary/protocol endpoint

Change in Mini Mental State Exam (MMSE)

Time frame:up to 64 days

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Behavior / neuropsychiatric

3 endpoints
Secondary/protocol endpoint

Change in the Cohen Mansfield Agitation Inventory (CMAI).

Time frame:up to 64 days

change from baseline, improvement

Secondary/protocol endpoint

rescue medication

Time frame:up to 64 days

event count, event

Secondary/protocol endpoint

Change in Sleep Disorders Inventory

Time frame:up to 64 days

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

drop-out's

Time frame:up to 64 days

event count, event

Primary/protocol endpoint

Adverse Events

Time frame:up to 64 days

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in The Edinburgh Feeding Evaluation in Dementia Scale

Time frame:up to 64 days

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.