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NAbiximols Clinical Translation To the treatment of Pain and Agitation In Severe Dementia (NACTOPAISD): Clinical trial protocol.

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Title: NAbiximols Clinical Translation To the treatment of Pain and Agitation In Severe Dementia (NACTOPAISD): Clinical trial protocol.
Authors: Scuteri, D., Guida, F., Boccella, S., Luongo, L., Maione, S., Tonin, P., Nicotera, P., Bagetta, G., Corasaniti, M. T.
Source: Biomedicine & pharmacotherapy 153, 113488 (2022). doi:10.1016/j.biopha.2022.113488
Publisher Information: Elsevier
Publication Year: 2022
Subject Terms: info:eu-repo/classification/ddc/610, Aged, Cannabidiol: administration & dosage, Cannabidiol: adverse effects, Chronic Pain: drug therapy, Chronic Pain: etiology, Dementia: complications, Dementia: drug therapy, Double-Blind Method, Dronabinol: administration & dosage, Dronabinol: adverse effects, Drug Combinations, Humans, Oral Sprays, Psychomotor Agitation: drug therapy, Psychomotor Agitation: etiology, Randomized Controlled Trials as Topic, Agitation, CMAI, CONSORT, Cannabinoids, I-MOBID-2, Nabiximols, Pain, SPIRIT, Sativex®, Severe dementia, Cannabidiol, Dronabinol
Subject Geographic: DE
Description: Up to 80 % nursing home residents with dementia experiences chronic pain. Contextually, 97 % presents fluctuant neuropsychiatric symptoms (NPS). Among the most challenging is agitation, connected with undertreated pain and managed through neuroleptics doubling death risk. Evidence is accumulating in favor of the involvement of the endocannabinoid system in nociception and NPS. This double-blind, placebo-controlled, randomized trial (NAbiximols Clinical Translation To the treatment of Pain and Agitation In Severe Dementia [NACTOPAISD]) aims at investigating efficacy and safety of oral spray nabiximols, containing Δ9-tetrahydrocannabinol and cannabidiol (Sativex®), for pain and agitation treatment in severe dementia patients (Mini-Mental State Examination ≤ 12) over 65. The coprimary endpoints are efficacy on pain and agitation, assessed through the recently validated Italian Mobilization-Observation-Behavior-Intensity-Dementia and the Cohen-Mansfield Agitation Inventory. The secondary endpoint is the evaluation of efficacy duration after wash-out and the assessment of quality of life through the DEMQOL. Any adverse events will be reported. The results undergo statistical analysis plan. NACTOPAISD might provide rationale for a translational safer pain and agitation treatment in severe dementia. It is approved by Calabria Region Ethics Committee and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and the Consolidated Standards of Reporting Trials (CONSORT) statements.
Document Type: article in journal/newspaper
Language: English
ISSN: 0300-0893
0753-3322
1950-6007
Relation: info:eu-repo/semantics/altIdentifier/issn/0300-0893; info:eu-repo/semantics/altIdentifier/issn/0753-3322; info:eu-repo/semantics/altIdentifier/pmid/pmid:36076584; info:eu-repo/semantics/altIdentifier/issn/1950-6007; https://pub.dzne.de/record/165171
Availability: https://pub.dzne.de/record/165171
https://pub.dzne.de/search?p=id:%22DZNE-2022-01473%22
Rights: info:eu-repo/semantics/openAccess
Accession Number: edsbas.8BDAC086
Database: BASE
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  Data: Biomedicine & pharmacotherapy 153, 113488 (2022). doi:10.1016/j.biopha.2022.113488
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  Data: Up to 80 % nursing home residents with dementia experiences chronic pain. Contextually, 97 % presents fluctuant neuropsychiatric symptoms (NPS). Among the most challenging is agitation, connected with undertreated pain and managed through neuroleptics doubling death risk. Evidence is accumulating in favor of the involvement of the endocannabinoid system in nociception and NPS. This double-blind, placebo-controlled, randomized trial (NAbiximols Clinical Translation To the treatment of Pain and Agitation In Severe Dementia [NACTOPAISD]) aims at investigating efficacy and safety of oral spray nabiximols, containing Δ9-tetrahydrocannabinol and cannabidiol (Sativex®), for pain and agitation treatment in severe dementia patients (Mini-Mental State Examination ≤ 12) over 65. The coprimary endpoints are efficacy on pain and agitation, assessed through the recently validated Italian Mobilization-Observation-Behavior-Intensity-Dementia and the Cohen-Mansfield Agitation Inventory. The secondary endpoint is the evaluation of efficacy duration after wash-out and the assessment of quality of life through the DEMQOL. Any adverse events will be reported. The results undergo statistical analysis plan. NACTOPAISD might provide rationale for a translational safer pain and agitation treatment in severe dementia. It is approved by Calabria Region Ethics Committee and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and the Consolidated Standards of Reporting Trials (CONSORT) statements.
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