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CompletedPhase 2 / PHASE3

Safety and Efficacy of Nabilone in Alzheimer's Disease

Safety and Efficacy of Nabilone in Alzheimer's Disease: a Pilot Study

Asset

Nabilone

Listed sites

1

Recruiting sites

-

Enrollment

38

actual

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE ≤24

Primary endpoint

•Agitation

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 ID318-2013
NCT IDNCT02351882

Timeline

Milestones

Study start2015-01 (month precision)
Study first posted2015-01-30estimated
Primary completion2018-01actual (month precision)
Study completion2019-03actual (month precision)
Last update posted2020-06-25actual

Assets

Drug assets

Nabilone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Males or females ≥55 years of age
•Diagnostic and Statistical Manual (DSM) -V criteria for Major Neurocognitive Disorder due to AD. Patients with both Major Neurocognitive Disorder due to AD and Major Vascular Neurocognitive Disorder (i.e., mixed AD and cerebrovascular disease) will also be included.
•Currently in moderate-to-severe stage of dementia (Mini-Mental Status Examination (MMSE) ≤24)
•Presence of clinically significant agitation (Neuropsychiatric Inventory (NPI) agitation subscale ≥3)
•If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months. If the ChEI and/or memantine has been discontinued, they may enroll after 1 month

Exclusion criteria

•Change in psychotropic medications less than 1 month prior to study randomization (e.g., concomitant antidepressants)
•Contraindications to nabilone (history of hypersensitivity to any cannabinoid)
•Current or past significant cardiovascular disease (e.g. uncontrolled hypertension, ischemic heart disease, arrhythmia and severe heart failure)
•Presence or history of other psychiatric disorders or neurological conditions (e.g. psychotic disorders, schizophrenia, stroke, epilepsy), previous or current abuse of/dependence on marijuana

Endpoints (11)

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

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

Global cognition

3 endpoints
Secondary/protocol endpoint

Change in cognition; Standardized Mini-mental State Examination (sMMSE)

Time frame:baseline (0 weeks) to 14 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change in cognition; Severe Impairment Battery (SIB)

Time frame:baseline (0 weeks) to 14 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in cognition; Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)

Time frame:baseline (0 weeks) to 14 weeks

ADAS-Cog

change from baseline, improvement

Executive function / language

1 endpoint
Other/protocol endpoint

Change in pain; Pain Assessment In Advanced Dementia (PAINAD)

Time frame:baseline (0 weeks) to 14 weeks

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Change in agitation; Cohen-Mansfield Agitation Inventory (CMAI)

Time frame:baseline (0 weeks) to 14 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in neuropsychiatric symptoms; Neuropsychiatric Inventory (NPI)

Time frame:baseline (0 weeks) to 14 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Other/protocol endpoint

Change in heart rate

Time frame:baseline (0 weeks) to 14 weeks

change from baseline, event

Other/protocol endpoint

Change in blood pressure

Time frame:baseline (0 weeks) to 14 weeks

change from baseline, event

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Change in clinical representation; Alzheimer's Disease Cooperative Study - The Clinician Global Impression (ADCS - CGIC)

Time frame:2 to 14 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in nutritional status; Mini Nutritional Assessment - Short Form (MNA-SF)

Time frame:baseline (0 weeks) to 14 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in levels of blood biomarkers

Time frame:baseline (0 weeks) to 14 weeks

change from baseline, improvement

Publications (6)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.