Ignite Creation Date:
2024-05-05 @ 11:19 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01302340
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2011-02-10
Brief Title:
Delta-THC in Behavioral Disturbances in Dementia
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Two Phase Repeated Crossover Study With Dose Escalation on Delta9-Tetrahydrocannabinol Delta-THC in Behavioral Disturbances in Dementia
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Design Phase II pilot study multi-center repeated cross-over double blinded randomized trial The study consists of two weeks baseline measurements to assure that the neuropsychiatric symptoms are stable and six successive treatment blocks of 2 weeks Each treatment block lasts for two weeks and contains two double-blinded drug periods each lasting three days of oral THC or placebo separated by four day washout periods After three treatment blocks period A the dosage of active treatment was increased for the latter three treatment blocks period B After the two treatment periods subjects will proceed to the extension phase if applicable
Study centers The department of Geriatrics from Radboud University Nijmegen Medical Centre and the department of Elderly from Vincent van Gogh voor Geestelijke Gezondheidszorg Venray VVG will participate in this multi center study
Participants 20 subjects with dementia and NPS Intervention Namisol in doses of twice daily 075 mg tablet period A and twice daily 15 mg period B THC oral tablets Placebo of twice daily 075 mg and twice daily 15 mg oral tablets Outcome measures Primary outcome is NPI score secondary CMAI Zarit Burden scale Other outcomes include vital signs side-effects physical exam mobility and pharmacogenetics
Visits This study will be assessed fully ambulatory starting with a 5 hour clinical visit on day 1 and 8 of block 1 and a phone call on day 2 and 9 for assessment of Adverse Events Furthermore the research physician will conduct a weekly home visit weekly during the crossover phase for assessment of among others the primary outcome measure These visits will all be repeated in period B of the crossover phase
During the 6 month open label extension phase subjects will visit the clinic three times
Study centers The department of Geriatrics from Radboud University Nijmegen Medical Centre and the department of Elderly from Vincent van Gogh voor Geestelijke Gezondheidszorg Venray VVG will participate in this multi center study
Participants 20 subjects with dementia and NPS Intervention Namisol in doses of twice daily 075 mg tablet period A and twice daily 15 mg period B THC oral tablets Placebo of twice daily 075 mg and twice daily 15 mg oral tablets Outcome measures Primary outcome is NPI score secondary CMAI Zarit Burden scale Other outcomes include vital signs side-effects physical exam mobility and pharmacogenetics
Visits This study will be assessed fully ambulatory starting with a 5 hour clinical visit on day 1 and 8 of block 1 and a phone call on day 2 and 9 for assessment of Adverse Events Furthermore the research physician will conduct a weekly home visit weekly during the crossover phase for assessment of among others the primary outcome measure These visits will all be repeated in period B of the crossover phase
During the 6 month open label extension phase subjects will visit the clinic three times
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Supplies Investigational Drug | OTHER_GRANT | Echo pharmaceuticals | None |
| 2009-019329 | OTHER_GRANT | None | None |
| 2010-024577-39 | EUDRACT_NUMBER | None | None |