Ignite Creation Date:
2024-05-06 @ 12:34 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01608217
Status:
COMPLETED
Last Update Posted:
2014-06-30
First Post:
2012-05-25
Brief Title:
Delta-THC in Dementia
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Efficacy and Safety of Delta-9-tetrahydrocannabinol 9-THC in Behavioural Disturbances and Pain in Dementia
Status:
COMPLETED
Status Verified Date:
2014-06
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:
This is a phase II randomized placebo-controlled double-blind parallel-group multicentre study to the efficacy and safety of low dose delta-9-THC in behavioural disturbances and pain in patients with mild to severe dementia when added to an analgesic treatment with acetaminophen
It is hypothesized that Namisol will lead to more behavioural disturbances than placebo when added to an analgesic treatment with acetaminophen and as measured by a change in Neuropsychiatric Inventory NPI score after a three week treatment period
It is expected that this will be due primarily to psychoactive effects of Namisol and secondary to a reduction in pain sensation as measured with VRS and PACSLAC-D It is expected that a reduction in NPS will positively affect quality of life and lead to better functioning in daily living
It is hypothesized that Namisol will lead to more behavioural disturbances than placebo when added to an analgesic treatment with acetaminophen and as measured by a change in Neuropsychiatric Inventory NPI score after a three week treatment period
It is expected that this will be due primarily to psychoactive effects of Namisol and secondary to a reduction in pain sensation as measured with VRS and PACSLAC-D It is expected that a reduction in NPS will positively affect quality of life and lead to better functioning in daily living
Detailed Description:
There is a high prevalence of behavioural disturbances NPS in persons with dementia Persistent pain complaints can be a cause of NPS Unfortunately there is a lack of appropriate drugs for treating both these problems This and positive suggestions from preliminary clinical studies with THC on NPS and directly fuel the study presented here
This will be a phase II study in which the efficacy and safety of Namisol a tablet with THC on behavioural disturbances such as agitation aggression and motor disturbances in dementia patients will be evaluated
Secondary study objectives are
2 To evaluate the efficacy of Namisol on other secondary outcome measures such as quality of life and functioning in daily activities
3 To evaluate safety of Namisol as assessed with physical examination effects on cognitive functioning and adverse event monitoring
4 For the subgroup of subjects suffering from pain to evaluate the efficacy of Namisol pain intensity
It is hypothesized that Namisol will lead to more reduction in behavioural disturbances than placebo when added to an analgesic treatment with acetaminophen and as measured by a change in Neuropsychiatric Inventory NPI score after a three week treatment period It is expected that this will be due primarily to psychoactive effects of Namisol and secondary to a reduction in pain sensation as measured with VRS and PACSLAC-D It is expected that a reduction in NPS will positively affect quality of life and lead to better functioning in daily living
This is a randomized placebo-controlled double-blind parallel-group multicentre study
Subjects who appear to fulfill the eligibility criteria are informed about the study After signing informed consent by the subject andor caregiver a screening visit will take place Subjects who are eligible for participation enter a wash-out period for discontinuation of their own analgesic medication if applicable Subjects will be randomly allocated to receive one of the two interventions Namisol 15 mg acetaminophen 1000 mg three times daily or placebo acetaminophen 1000 mg three times daily for a double-blind intervention period of three weeks After two weeks the primary outcome measure NPI is assessed by a telephone interview with the caregiver Subjects visit the site twice at baseline and after three weeks treatment for assessments of the outcome parameters including the NPI For the purpose of compliance and safety there will be a weekly phone call performed by the researcher After completion of this period subjects own analgesic treatment will be restarted if applicable After a follow up phase of two weeks the subject is contacted by telephone for assessment of adverse events
This will be a phase II study in which the efficacy and safety of Namisol a tablet with THC on behavioural disturbances such as agitation aggression and motor disturbances in dementia patients will be evaluated
Secondary study objectives are
2 To evaluate the efficacy of Namisol on other secondary outcome measures such as quality of life and functioning in daily activities
3 To evaluate safety of Namisol as assessed with physical examination effects on cognitive functioning and adverse event monitoring
4 For the subgroup of subjects suffering from pain to evaluate the efficacy of Namisol pain intensity
It is hypothesized that Namisol will lead to more reduction in behavioural disturbances than placebo when added to an analgesic treatment with acetaminophen and as measured by a change in Neuropsychiatric Inventory NPI score after a three week treatment period It is expected that this will be due primarily to psychoactive effects of Namisol and secondary to a reduction in pain sensation as measured with VRS and PACSLAC-D It is expected that a reduction in NPS will positively affect quality of life and lead to better functioning in daily living
This is a randomized placebo-controlled double-blind parallel-group multicentre study
Subjects who appear to fulfill the eligibility criteria are informed about the study After signing informed consent by the subject andor caregiver a screening visit will take place Subjects who are eligible for participation enter a wash-out period for discontinuation of their own analgesic medication if applicable Subjects will be randomly allocated to receive one of the two interventions Namisol 15 mg acetaminophen 1000 mg three times daily or placebo acetaminophen 1000 mg three times daily for a double-blind intervention period of three weeks After two weeks the primary outcome measure NPI is assessed by a telephone interview with the caregiver Subjects visit the site twice at baseline and after three weeks treatment for assessments of the outcome parameters including the NPI For the purpose of compliance and safety there will be a weekly phone call performed by the researcher After completion of this period subjects own analgesic treatment will be restarted if applicable After a follow up phase of two weeks the subject is contacted by telephone for assessment of adverse events
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 |
|---|---|---|---|
| NL3861709112 | REGISTRY | toetsingonlinecom | None |
| 2011-005289-39 | EUDRACT_NUMBER | None | None |