Two phase, repeated crossover study with dose escalation on Delta(9)-tetrahydrocannabinol (Delta-THC) in behavioral disturbances in dementia. - Delta-THC in Behavioral Disturbances in Dementia

• Conditions: Patients with mild to moderate dementia on the clinical dementia rating scale (Clinical Dementia Rating [CDR] score 0.5-2). Included patients must have a completed NPI with a minimum score of 10 (or at least 1 item with high frequency and severity). Furthermore patients should have symptoms of agitation or aggression; MedDRA version: 12.1Level: PTClassification code 10012267Term: Dementia; MedDRA version: 12.1Level: PTClassification code 10012271Term: Dementia Alzheimer's type; MedDRA version: 12.1Level: PTClassification code 10057678Term: Vascular dementia; MedDRA version: 12.1Level: PTClassification code 10066842Term: Behavioural and psychiatric symptoms of dementia

• Registration Number: EUCTR2010-024577-39-NL
• Lead Sponsor: Province of Gelderland & Overijssel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of Alzheimer's Disease, Vascular Dementia or mixed, according to the criteria of NINCDS-ADRDA/NINCDS-AIREN
2. Clinical Dementia Rating score between 0.5 and 2
3. Behavioral problems (especially agression or agitation) related to dementia, lasting for at least one month).
4. Informed consent from patient and/or from caregiver (according to WMO)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosis of Lewy Body Dementia or Fronto Temporal Dementia
2. Major psychiatric disorder: major depression (meeting DSM-IV criteria) within 6 months prior to randomization, history of, or current psychosis, current hallucinations and/or delirium
3. Severe concomitant illness, seizure, arrhythmias (except sinusarrhythmia and atrial fibrillation) requiring other drugs than a beta blocker or digoxin, heart failure NYHA III or IV
4. Tricyclic Antidepressiva or opioids used within 30 days before randomization till the end of the study
5. Changes in psychotropic medication during study participation, more specific: changes in dosage of antidepressiva within 6 weeks before randomization and during study, and changes in dosage antipsychotics or benzodiazepines within 2 weeks prior to randomization and during study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified