Subjects with mild to severe Alzheimer's dementia and/or vascular dementia with behavioural disturbances, with at least agitation, aggression or aberrant motor disturbances. MedDRA version: 16.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1 Level: PT Classification code 10057678 Term: Vascular dementia System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1 Level: PT Clas
Conditions
Interventions
Product Name: Namisol (delta-9-tetrahydrocannabinol)
Product Code: ECP002A
Pharmaceutical Form: Tablet
INN or Proposed INN: DRONABINOL
CAS Number: 03/08/1972
Current Sponsor code: ECP002A
Other descri
Sponsors
Radboud university medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject has possible or probable dementia, type AD, VaD or AD/VaD, 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). - Clinically relevant behavioural 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. - Informed consent by the subject and subject’s informal caregiver. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: - Dementia other than AD, VaD or AD/VaD - Major psychiatric disorder - History of, or current drug abuse. - Current alcohol abuse or unwillingness to use no more than 2 alcoholic consumptions daily - Severe (and/or unstable) concomitant or intercurrent illness - Clinical or biochemical evidence of liver disease (ALT or AST = twice the upper limit of normal) or known allergy to acetaminophen. - Use of tricyclic antidepressants (TCA), carbamazepine or fluoxetine. - Changes in dosage of antipsychotics, benzodiazepines or cholinesterase inhibitors within 2 weeks prior to intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of Namisol® behavioural disturbances, such as agitation, aggression and aberrant motor disturbances in patients with dementia, when added to a treatment with acetaminophen.;Secondary Objective: - To evaluate the efficacy of Namisol® on other secondary outcome measures, such as quality of life and functioning in daily activities. - To evaluate safety of Namisol® as assessed with physical examination, effects on cognitive functioning and adverse event monitoring. - To evaluate the efficacy of Namisol® pain intensity. - For the subgroup of subjects suffering from pain: to evaluate the efficacy of Namisol® on pain intensity ;Primary end point(s): Neuropsychiatric Inventory (NPI);Timepoint(s) of evaluation of this end point: At screening, baseline (T=0), T=2 weeks (by telephone interview) and T= 3 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Verbal Rating Scale (VRS) - Pain Assessment Checklist for Seniors with Limited Ability to Communicate Dutch version (PACSLAC-D) - Caregiver Clinical Global Impression of Change (CCGIC) - Cohen-Mansfield Agitation Inventory (CMAI) - Barthel Index - Quality of Life Alzheimer's disease (QoL-AD) - Paired Associates Learning test (PAL WMS-R) - Safety parameters: vital signs, physical examination, ECG, adverse events etc.;Timepoint(s) of evaluation of this end point: All outcome measurements will be assessed at baseline (T= 0) and T= 3 weeks. The VRS will also be assessed at screening and follow up (phone call) and daily in a study medication diary. CCGIC will also be assessed at T= 2 weeks (by phone call interview) Adverse events will be recorded from signing informed consent onwards | — |
Countries
Netherlands
Contacts
Public ContactMarcel Olde Rikkert
Radboud university medical center
Outcome results
None listed