Jacob Bell
New Member
Open-label study of dronabinol in the treatment of refractory agitation in Alzheimer�s disease: a pilot study
Author(s) Ross JS, Shua-Haim JR
Journal, Volume, Issue Abstract, American Society of Consultant Pharmacists' 34th Annual Meeting, November 12-15, 2003.
Major outcome(s) Significant reduction of agitation
Indication Alzheimer's disease
Medication Delta-9-THC
Route(s) Oral
Dose(s) 2 x 2,5 mg or 2 x 5 mg
Duration (days) 56
Participants 54 patients with AD
Design Open study
Type of publication Meeting abstract
Address of author(s) Monmouth Medical Center, Long Branch, NJ, USA
Abstract
Objectives: Primary, to investigate the efficacy of two doses of dronabinol for the treatment of behavioral agitation in community-dwelling patients with Alzheimer�s disease (AD). Secondary, to evaluate two doses of dronabinol in improving the patient�s global functioning and to determine the effects of two doses of dronabinol on the caregiver�s burden, strain (distress), and quality of life.
Design: A phase II, open-label, eight-week study in a total of 54 patients with AD. Twenty-seven patients were randomly assigned to Group 1�dronabinol 2.5 mg bid and 27 to Group 2�dronabinol 5.0 mg bid. The primary efficacy measurement was the Cohen-Mansfield Agitation Inventory (CMAI), a 38-item rating scale that evaluates the prevalence of pathological and disruptive behaviors, rating each on a seven-point scale of frequency ranging from 0 to 6. The secondary efficacy measurements were the Caregiver�s Burden Inventory (CBI), CGI Severity of Alzheimer�s Disease (CGI-S AD), Instrumental Activities of Daily Living scale (IADL), and Mini-Mental State Examination (MMSE).
Results: Significant reductions in CMAI scores were observed at both dronabinol dose levels (2.5: P<0.001, 5.0: P=0.024). The difference between the two groups was not statistically significant. Percent reductions in CMAI scores were statistically significant for both groups (2.5: P<0.001, 5.0: P=0.048). There was a trend toward a decrease in CBI scores, with no statistical difference between treatment groups. There was a trend toward a decrease in CGI-S AD scores in the dronabinol 5.0-mg bid group. There was a trend toward an increase in IADL scores with no difference between groups. There was no difference between groups in MMSE.
Conclusion: The results from the CMAI assessment indicated that dronabinol at both 2.5 mg bid and 5.0 mg bid were effective treatments for behavioral agitation in community-dwelling AD patients. There was not a significant difference between the doses of dronabinol in CMAI scores and most secondary efficacy parameters.
Benefit: Dronabinol was found to be an effective treatment for behavioral agitation in community-dwelling patients with AD.
Source: Open-label study of dronabinol in the treatment of refractory agitation in Alzheimer�s disease: a pilot study
Author(s) Ross JS, Shua-Haim JR
Journal, Volume, Issue Abstract, American Society of Consultant Pharmacists' 34th Annual Meeting, November 12-15, 2003.
Major outcome(s) Significant reduction of agitation
Indication Alzheimer's disease
Medication Delta-9-THC
Route(s) Oral
Dose(s) 2 x 2,5 mg or 2 x 5 mg
Duration (days) 56
Participants 54 patients with AD
Design Open study
Type of publication Meeting abstract
Address of author(s) Monmouth Medical Center, Long Branch, NJ, USA
Abstract
Objectives: Primary, to investigate the efficacy of two doses of dronabinol for the treatment of behavioral agitation in community-dwelling patients with Alzheimer�s disease (AD). Secondary, to evaluate two doses of dronabinol in improving the patient�s global functioning and to determine the effects of two doses of dronabinol on the caregiver�s burden, strain (distress), and quality of life.
Design: A phase II, open-label, eight-week study in a total of 54 patients with AD. Twenty-seven patients were randomly assigned to Group 1�dronabinol 2.5 mg bid and 27 to Group 2�dronabinol 5.0 mg bid. The primary efficacy measurement was the Cohen-Mansfield Agitation Inventory (CMAI), a 38-item rating scale that evaluates the prevalence of pathological and disruptive behaviors, rating each on a seven-point scale of frequency ranging from 0 to 6. The secondary efficacy measurements were the Caregiver�s Burden Inventory (CBI), CGI Severity of Alzheimer�s Disease (CGI-S AD), Instrumental Activities of Daily Living scale (IADL), and Mini-Mental State Examination (MMSE).
Results: Significant reductions in CMAI scores were observed at both dronabinol dose levels (2.5: P<0.001, 5.0: P=0.024). The difference between the two groups was not statistically significant. Percent reductions in CMAI scores were statistically significant for both groups (2.5: P<0.001, 5.0: P=0.048). There was a trend toward a decrease in CBI scores, with no statistical difference between treatment groups. There was a trend toward a decrease in CGI-S AD scores in the dronabinol 5.0-mg bid group. There was a trend toward an increase in IADL scores with no difference between groups. There was no difference between groups in MMSE.
Conclusion: The results from the CMAI assessment indicated that dronabinol at both 2.5 mg bid and 5.0 mg bid were effective treatments for behavioral agitation in community-dwelling AD patients. There was not a significant difference between the doses of dronabinol in CMAI scores and most secondary efficacy parameters.
Benefit: Dronabinol was found to be an effective treatment for behavioral agitation in community-dwelling patients with AD.
Source: Open-label study of dronabinol in the treatment of refractory agitation in Alzheimer�s disease: a pilot study
