Efficacy and safety of delta-9-tetrahydrocannabinol (delta-THC) in behavioural disturbances in dementia

Phase 2

Completed

• Conditions: probleemgedrag; Alzheimer's disease; Dementia; 10012272

• Registration Number: NL-OMON39470
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

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.;- if applicable: subject agrees with temporarily stopping analgesic drugs for the duration of the study;- Informed consent by the subject and subject*s informal caregiver.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified