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CompletedPhase 2

Delta-THC in Dementia

Efficacy and Safety of Delta-9-tetrahydrocannabinol (∆9-THC) in Behavioural Disturbances and Pain in Dementia

Assets

Acetaminophen / Dronabinol

Listed sites

2

Recruiting sites

-

Enrollment

50

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

Eudract number2011-005289-39
Org study IDGER001-02-02
NCT IDNCT01608217
RegistryNL38617.091.12toetsingonline.com

Timeline

Milestones

Study first posted2012-05-31estimated
Study start2012-06 (month precision)
Primary completion2014-06actual (month precision)
Study completion2014-06actual (month precision)
Last update posted2014-06-30estimated

Assets

Drug assets

AcetaminophenDronabinol

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementiaMixed / unspecified dementia

Eligibility

Who can enroll

Minimum age40 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Subject has possible or probable dementia, type Alzheimer, vascular or mixed type dementia, according to the criteria of NINCDS-ADRDA/NINCDS-AIREN or based on an expert panel decision.
•Clinical Dementia Rating (CDR) score 1 to 3 (mild to severe dementia).
•Age ≥ 40 years.
•Clinically relevant behavioral disturbances existing at least one month prior to screening, defined as a score of ≥ 10 on the NPI, including presence of the domain agitation/aggression or motor disturbance.
•Women should be in the postmenopausal phase.
•Availability of an informal or formal caregiver, being in touch with the subject at least twice a week.
•Informed consent by the subject and subject's informal caregiver.
•If applicable: subject is willing to stop his/her own pain medication, for the duration of the study

Exclusion criteria

•Dementia other than AD, VaD or AD/VaD
•Major psychiatric disorder such as: major depression according to DSM IV within 6 months prior to randomization, history of psychosis or mania, current hallucinations and/or delirium, current suicidal ideation or major anxiety disorder.
•History of, or current drug abuse.
•Current alcohol abuse or unwillingness to use no more than 2 alcoholic consumptions daily or raised gamma-glutamine transpeptidase and alkaline phosphatase .
•Clinical or biochemical evidence of liver disease (ALT or AST ≥ twice the upper limit of normal) or known allergy to acetaminophen.
•Severe (and/or unstable) concomitant or intercurrent illness, such as seizure, arrhythmias requiring other drugs than a beta blocker or digoxin (except sinus arrhythmia and atrial fibrillation), unstable angina pectoris, heart failure NYHA III or IV, and severe concomitant illness that requires treatment changes.
•Known or suspected sensitivity to cannabinoids.
•Lactosis intolerance.
•Frequent falling due to orthostatic hypotension.
•Use of tricyclic antidepressants (TCA), fluoxetine and/or carbamazepine.
•Changes in dosage of antipsychotics, benzodiazepines or cholinesterase inhibitors within 2 weeks prior to intervention.
•Participation in any other study other than the descriptive 'Parelsnoer' 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

Behavior / neuropsychiatric
3
Caregiver / quality of life
2
Global cognition
1
Memory
1
Function / daily living
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Verbal Rating Scale (VRS)

Time frame:screening, baseline, T= 3 weeks, follow up (T= 5 weeks) and daily in a medication diary

descriptive

Memory

1 endpoint
Secondary/protocol endpoint

Paired Associates Learning test Wechsler Memory Scale Revised(PAL WMS-R)

Time frame:baseline (T = 0) and T = 3 weeks

descriptive

Function / daily living

1 endpoint
Secondary/protocol endpoint

Barthel Index

Time frame:baseline (T=0) and T = 3 weeks

descriptive

Behavior / neuropsychiatric

3 endpoints
Primary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:Screening, baseline, T= 2 weeks (by telephone interview) and T=3 weeks

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Pain Assessment Checklist for Seniors with Limited Ability to Communicate Dutch version (PACSLAC-D)

Time frame:baseline (T = 0) and T= 3 weeks

descriptive

Secondary/protocol endpoint

Cohen-Mansfield Agitation Inventory (CMAI)

Time frame:baseline (T=0) and T= 3 weeks

descriptive

Caregiver / quality of life

2 endpoints
Secondary/protocol endpoint

Caregiver Clinical Global Impression of Change (CCGIC)

Time frame:baseline (T=0), T= 2 wks (by telephone interview) and T=3 wks

change from baseline, improvement

Secondary/protocol endpoint

Quality of Life-Alzheimer's Disease Scale (QoL-AD)

Time frame:baseline (T=0) and T= 3 weeks

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Safety assessments

Time frame:screening, baseline (T=0), T= 3 weeks. AE and compliance during telephone calls at T= 1week, T= 2 weeks and T= 5 weeks (follow up phone call)

event count, event

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.