Dementia Clinical Trial
Official title:
Two Phase, Repeated Crossover Study With Dose Escalation on Delta(9)-Tetrahydrocannabinol (Delta-THC) in Behavioral Disturbances in Dementia
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud university medical center | Nijmegen | Gelderland |
Netherlands | Vincent van Gogh Institute for Psychiatry, department of Elderly | Venray | Limburg |
Lead Sponsor | Collaborator |
---|---|
Radboud University | European Union |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Cohen-Mansfield Agitation Inventory (CMAI) | Improvement in agitation compared to placebo and during long term treatment is measured with CMAI. It is useful in determining fluctuations in behaviors and emotional states in Alzheimer's Disease | 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 | No |
Secondary | Zarit Burden Scale (ZBS) | Reducing caregiver stress compared to placebo and during long term treatment by focusing on the patients' behavior compared to Zarit burden interviews with the caregiver. | At days 3 and 10 during treatment blocks and months 1, 3 and 6 during extension phase | No |
Secondary | Visual Analogue Scale (VAS) Bowdle for feeling high | severity and duration of feeling high episodes | 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 | Yes |
Secondary | Gait rite® | Improvement and/or safety compared to placebo and during long term treatment on balance and mobility. It is a non invasive and highly feasible mobility assessment. | At days 1 and 8 during blocks 1 and 4 and at 1, 3 and 6 months during extension phase | Yes |
Secondary | Sway Star® | Improvement and/or safety compared to placebo and during long term treatment on balance and mobility. It is a non invasive and highly feasible mobility assessments. | At days 1 and 8 during blocks 1 and 4 and at 1, 3 and 6 months during extension phase | Yes |
Secondary | Time up and go | Improvement and/or safety compared to placebo and during long term treatment on balance and mobility in elderly patients. | 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 | Yes |
Secondary | Tinetti Balance Assessment Tool | Improvement and/or safety compared to placebo and during long term treatment on balance and mobility in elderly patients. It is a performance-oriented assessment of mobility problems in elderly patients. | 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 | Yes |
Secondary | pharmacogenetics | The following polymorphisms will be genotyped: CYP2C9*2 CYP2C9*3 CYP2C19*2 CYP2C19*3 CYP2C19*17 To investigate the role of CYP2C9 and CYP2C19 genetic polymorphisms in the interindividual variation in pharmacokinetics, efficacy and adverse events of THC. |
day 1 | No |
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