THC in behavioural problems and pain in dementia

Phase 1

• Conditions: 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: 16.1Level: PTClassification code 10012267Term: DementiaSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 16.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 16.1Level: PTClassification code 10057678Term: Vascular dementiaSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 16.1Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; MedDRA version: 16.1Level: PTClassification code 10066842Term: Behavioural and psychiatric symptoms of dementiaSystem Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2011-005289-39-NL
• Lead Sponsor: Radboud university medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-13
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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.
- 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

- 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 clinical trial of medicinal product
• Study Design: Not specified