NCT01302340

Brief Summary

Dementia is a common chronic condition, with predicted increasing prevalence. Nearly all patients with dementia will experience neuropsychiatric symptoms (NPS). This causes significant burden for the individual patients and their caregivers. Current treatment has only modest efficacy and important side-effects. Formulations with Δ9-tetrahydrocannabinol (THC), the psycho-active compound of cannabis, are currently being registered for spasms in multiple sclerosis and other diseases, and may have beneficial effects on NPS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

2.3 years

First QC Date

February 10, 2011

Last Update Submit

January 21, 2014

Conditions

Dementia

Keywords

DementiaAlzheimerCannabisTHCBehavioral DisturbancesNeuropsychiatric Inventory

Outcome Measures

Primary Outcomes (1)

  • Neuropsychiatric Inventory (NPI)

    Improvement in behavior compared to placebo is measured with the NPI, which is the standard measure of Neuro Psychiatric Symptoms in most clinical trials.

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

Secondary Outcomes (8)

  • Cohen-Mansfield Agitation Inventory (CMAI)

    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

  • Zarit Burden Scale (ZBS)

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

  • Visual Analogue Scale (VAS) Bowdle for feeling high

    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

  • Gait rite®

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

  • Sway Star®

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

  • +3 more secondary outcomes

Study Arms (2)

Delta-THC

ACTIVE COMPARATOR

THC will be administered twice daily during three consecutive days per treatment block(0.75 or 1.5 mg twice daily)

Drug: Delta-THC

placebo

PLACEBO COMPARATOR

Placebo will be administered twice daily during three consecutive days per treatment block.

Drug: placebo

Interventions

Delta-THCDRUG

Active treatment consists of THC in tablet form. Patients receive 0.75 mg THC twice daily during the first three treatment blocks (period A) and 1.5 mg THC twice daily during the latter three treatment blocks (period B). Placebo treatment consists of two tablets daily and is matched to the active treatment for taste, color and size. Study medication will be administered at 10 a.m. and 4 p.m., by the primary caregiver. These time points are chosen because NPS often occur later on the day, when fatigue and external signals build up to the stress and result in NPS. The order of administration of THC and placebo (1:1) will be determined by randomization per block: THC followed by placebo or placebo followed by THC.

Also known as: Namisol, Cannabis, ECP002A
Delta-THC
placeboDRUG

Active treatment consists of THC in tablet form. Patients receive 0.75 mg THC twice daily during the first three treatment blocks (period A) and 1.5 mg THC twice daily during the latter three treatment blocks (period B). Placebo treatment consists of two tablets daily and is matched to the active treatment for taste, color and size. Study medication will be administered at 10 a.m. and 4 p.m., by the primary caregiver. These time points are chosen because NPS often occur later on the day, when fatigue and external signals build up to the stress and result in NPS. The order of administration of THC and placebo (1:1) will be determined by randomization per block: THC followed by placebo or placebo followed by THC.

Also known as: Placebo Namisol
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboud university medical center

Nijmegen, Gelderland, 6525EX, Netherlands

Location

Vincent van Gogh Institute for Psychiatry, department of Elderly

Venray, Limburg, 5803, Netherlands

Location

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

MeSH Terms

Conditions

DementiaMarijuana AbuseMental Disorders

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Marcel Olde Rikkert, prof MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 24, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

NL(2)