Delta-THC in Dementia
Efficacy and Safety of Delta-9-tetrahydrocannabinol (∆9-THC) in Behavioural Disturbances and Pain in Dementia
3 other identifiers
interventional
50
1 country
2
Brief Summary
This is a phase II, randomized, placebo-controlled, double-blind, parallel-group, multicentre study to the efficacy and safety of low dose delta-9-THC in behavioural disturbances and pain in patients with mild to severe dementia, when added to an analgesic treatment with acetaminophen. It is hypothesized that Namisol® will lead to more behavioural disturbances than placebo, when added to an analgesic treatment with acetaminophen, and as measured by a change in Neuropsychiatric Inventory (NPI) score, after a three week treatment period. It is expected that this will be due, primarily, to psychoactive effects of Namisol® and secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is expected that a reduction in NPS will positively affect quality of life and lead to better functioning in daily living.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 30, 2014
June 1, 2014
2 years
May 25, 2012
June 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neuropsychiatric Inventory (NPI)
The NPI has been accepted as the standard measure of NPS in most clinical trials, due to high validity, good inter-rater reliability, high internal consistency and its sensitivity to drug treatment effects. In clinical practice as well as clinical research the NPI is the most commonly used instrument to assess behavioral changes. The NPI evaluates 12 behavioral domains. The frequency and severity of these behaviors is scored by the informal caregiver.
Screening, baseline, T= 2 weeks (by telephone interview) and T=3 weeks
Secondary Outcomes (8)
Pain Assessment Checklist for Seniors with Limited Ability to Communicate Dutch version (PACSLAC-D)
baseline (T = 0) and T= 3 weeks
Caregiver Clinical Global Impression of Change (CCGIC)
baseline (T=0), T= 2 wks (by telephone interview) and T=3 wks
Cohen-Mansfield Agitation Inventory (CMAI)
baseline (T=0) and T= 3 weeks
Quality of Life-Alzheimer's Disease Scale (QoL-AD)
baseline (T=0) and T= 3 weeks
Barthel Index
baseline (T=0) and T = 3 weeks
- +3 more secondary outcomes
Study Arms (2)
Namisol
ACTIVE COMPARATORNamisol is a tablet containing delta-9-tetrahydrocannabinol, the main cannabinoid from Cannabis sativa L. Namisol is added to a standardized treatment with acetaminophen.
Placebo
PLACEBO COMPARATORThe control product is placebo, consisting of a tablet with similar appearance and taste of the test product. Placebo is added to a standardized treatment with acetaminophen.
Interventions
delta-THC 1.5 mg (tablet)three times daily for a period of 3 weeks.
Acetaminophen 1000 mg three times daily for a period of 3 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Health Valley, Netherlandscollaborator
Study Sites (2)
Radboud university medical center, department of Geriatrics
Nijmegen, Gelderland, 6525, Netherlands
Vincent van Gogh Institute for Psychiatry, department of Elderly
Venlo, Limburg, 5912, Netherlands
Related Publications (1)
Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, Rubic Z, Vuica Vukasovic A, Jeroncic A, Puljak L. Cannabinoids for the treatment of dementia. Cochrane Database Syst Rev. 2021 Sep 17;9(9):CD012820. doi: 10.1002/14651858.CD012820.pub2.
PMID: 34532852DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcel Olde Rikkert, prof. dr.
Radboud University Medical Center Nijmegen
- PRINCIPAL INVESTIGATOR
Willem Verhoeven, Prof. dr.
Vincent van Gogh voor Geestelijke Gezondheidszorg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. Marcel Olde Rikkert
Study Record Dates
First Submitted
May 25, 2012
First Posted
May 31, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 30, 2014
Record last verified: 2014-06