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CompletedPhase 2

Delta-THC in Behavioral Disturbances in Dementia

Two Phase, Repeated Crossover Study With Dose Escalation on Delta(9)-Tetrahydrocannabinol (Delta-THC) in Behavioral Disturbances in Dementia

Asset

Dronabinol

Listed sites

2

Recruiting sites

-

Enrollment

22

actual

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia, Mixed / unspecified dementia

Key I/E criterion

•Multiple dementia etiologies

Primary endpoint

•Neuropsychiatric Inventory (NPI)

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

Other grant2009-019329Province of Gelderland&Overijssel
Eudract number2010-024577-39
Org study IDGER001-02-01
NCT IDNCT01302340
Other grantSupplies Investigational DrugEcho pharmaceuticals

Timeline

Milestones

Study first posted2011-02-24estimated
Study start2011-09 (month precision)
Primary completion2013-12actual (month precision)
Study completion2013-12actual (month precision)
Last update posted2014-01-22estimated

Assets

Drug assets

Dronabinol

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementiaMixed / unspecified dementia

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of Alzheimer's Disease (AD), Vascular Dementia (VD) or mixed, according to the criteria of NINCDS-ADRDA or NINCDS-AIREN
•Clinical Dementia Rating score between 0.5 and 3
•NPS symptoms, with at least agitation or aggression

Exclusion criteria

•Diagnosis of Lewy Body Dementia (LBD) or Fronto-Temporal Dementia (FTD)
•Major psychiatric disorder
•Severe concomitant illness, seizure, arrhythmias (except sinus arrhythmia and atrial fibrillation), heart failure New York Heart Association (NYHA) class III or IV
•Tri Cyclic Antidepressives (TCA) or opioids used within 30 days before randomization till the end of the study
•Changes in dosage of antidepressives within 6 weeks before randomization and during study, and changes in dosage antipsychotics or benzodiazepines within 2 weeks prior to randomization and during study

Endpoints (9)

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

Safety / tolerability / PK
5
Behavior / neuropsychiatric
3
Other (unclassified)
1

Behavior / neuropsychiatric

3 endpoints
Primary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:At day 3 and 10 during treatment blocks and after 1 month, 3 months and 6 months in the open label extension phase

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Cohen-Mansfield Agitation Inventory (CMAI)

Time frame:At days 1, 3, 8, and 10 during treatment blocks 1 and 4 and weekly during treatment blocks 2, 3, 5 and 6 and months 1, 3, 6 and 6 during extension phase

change from baseline, improvement

Secondary/protocol endpoint

Zarit Burden Scale (ZBS)

Time frame:At days 3 and 10 during treatment blocks and months 1, 3 and 6 during extension phase

descriptive

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Gait rite®

Time frame:At days 1 and 8 during blocks 1 and 4 and at 1, 3 and 6 months during extension phase

descriptive

Secondary/protocol endpoint

Sway Star®

Time frame:At days 1 and 8 during blocks 1 and 4 and at 1, 3 and 6 months during extension phase

descriptive

Secondary/protocol endpoint

Time up and go

Time frame:At days 1, 3, 8, and 10 during treatment blocks 1 and 4 and weekly during treatment blocks 2, 3, 5 and 6 and months 1, 3, 6 and 6 during extension phase

descriptive

Secondary/protocol endpoint

Tinetti Balance Assessment Tool

Time frame:At days 1, 3, 8, and 10 during treatment blocks 1 and 4 and weekly during treatment blocks 2, 3, 5 and 6 and months 1, 3, 6 and 6 during extension phase

descriptive

Secondary/protocol endpoint

pharmacogenetics

Time frame:day 1

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Visual Analogue Scale (VAS) Bowdle for feeling high

Time frame:At days 1, 3, 8, and 10 during treatment blocks 1 and 4 and weekly during treatment blocks 2, 3, 5 and 6 and months 1, 3, 6 and 6 during extension phase

ratio, descriptive

Publications (1)

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.