{"doi":"10.1016/j.jalz.2018.06.2871","title":"F4‐02‐04: NABILONE SIGNIFICANTLY IMPROVES AGITATION/AGGRESSION IN PATIENTS WITH MODERATE‐TO‐SEVERE AD: PRELIMINARY RESULTS OF A PLACEBO‐CONTROLLED, DOUBLE‐BLIND, CROSS‐OVER TRIAL","abstract":null,"journal":"Alzheimer's & Dementia","year":2018,"id":648994,"datarank":0.26876392038420827,"base_score":1.791759469228055,"endowment":1.791759469228055,"self_citation_contribution":0.26876392038420827,"citation_network_contribution":0.0,"self_endowment_contribution":0.26876392038420827,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":5,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":463081,"name":"Myuri Ruthirakuhan","orcid":"0000-0003-0308-2593","position":1,"is_corresponding":false},{"id":1048372,"name":"Damien Gallagher","orcid":"0000-0001-8952-3200","position":2,"is_corresponding":false},{"id":248121,"name":"Chelsea Sherman","orcid":null,"position":3,"is_corresponding":false},{"id":1691620,"name":"Eleenor H. Abraham","orcid":null,"position":4,"is_corresponding":false},{"id":1691622,"name":"Nicolaas Paul L.G. Verhoeff","orcid":null,"position":5,"is_corresponding":false},{"id":481337,"name":"Andrea Iaboni","orcid":"0000-0003-4268-6832","position":6,"is_corresponding":false},{"id":431865,"name":"Sandra E. Black","orcid":"0000-0001-7093-8289","position":7,"is_corresponding":false},{"id":976456,"name":"Ana C. Andreazza","orcid":"0000-0002-4323-7273","position":8,"is_corresponding":false},{"id":332727,"name":"Alex Kiss","orcid":null,"position":9,"is_corresponding":false},{"id":244608,"name":"Nathan Herrmann","orcid":"0000-0001-9277-6110","position":10,"is_corresponding":false},{"id":1691616,"name":"Krista L. Lanctot","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"F4‐02‐04: NABILONE SIGNIFICANTLY IMPROVES AGITATION/AGGRESSION IN PATIENTS WITH MODERATE‐TO‐SEVERE AD: PRELIMINARY RESULTS OF A PLACEBO‐CONTROLLED, DOUBLE‐BLIND, CROSS‐OVER TRIAL","abstract":"Agitation is a common and persistent symptom in those with Alzheimer's disease (AD) and current pharmacotherapies have modest efficacy and/or poor safety. We assessed the efficacy and safety of nabilone for the treatment of agitation in AD. This 14-week, randomized, double-blind, placebo-controlled cross-over trial compared 6 weeks of nabilone (1-2mg) to 6 weeks of placebo, with a 1-week washout between treatment phases. Moderate-to-severe AD patients (standardized Mini-Mental Status Exam (sMMSE)≤24) with clinically significant agitation (Neuropsychiatric Inventory (NPI)-agitation/aggression subscore≥3), were recruited from Long Term Care or outpatient psychiatry clinics. The primary outcome was agitation, as measured by the Cohen Mansfield Agitation Inventory (CMAI). Secondary outcomes included safety, overall neuropsychiatric symptoms (NPI total), cognition (sMMSE) and global impression (Clinician's Global Impression of Change (CGIC). Exploratory outcomes included pain (Pain Assessment in Advanced Dementia Scale (PAINAD)) and nutritional status (Mini-Nutritional Assessment-Short Form (MNA-SF)). Thirty-nine patients (mean±SD age=87±10, sMMSE=6.5±6.8, CMAI=67.9±17.6, NPI total score=34.3±15.8, 77% male) were randomized. The mean therapeutic dose of nabilone achieved was 1.6±0.5 mg. The estimated treatment difference in CMAI score was b= -4.0 (95%CI -6.5 to -1.5, p=0.003) favouring nabilone with no cross-over (t(32)=1.6, p=0.11) or treatment-order (t(31)=0.2, p=0.85) effects. There were also significant differences in NPI-agitation/aggression (b= -1.5, 95%CI -2.3 to -0.6, p=0.001), NPI total (b= -4.6, 95%CI -7.5 to -1.6, p=0.004), and sMMSE (b= 1.1, 95%CI 0.1 to 2.0, p=0.026) favouring nabilone. On the CGIC, 47% and 23% of patients experienced improvement during the nabilone and placebo phases, respectively (McNemar's test, p=0.09). More patients experienced sedation on nabilone (45%) compared to placebo (16%) (McNemar's test, p=0.02), with no difference in treatment-limiting sedation (McNemar's test, p=0.22). There were treatment differences on the MNA-SF (b= 0.2, 95%CI 0.02 to 0.4, p=0.03), which favoured nabilone, but not on PAINAD (b= 0.03, 95%CI -0.22 to 0.27, p=0.82). Nabilone significantly improved agitation, NPS, cognition and nutrition in patients with moderate-to-severe AD. However, the occurrence of sedation should be closely monitored. A larger trial with nabilone to provide confirmatory evidence regarding the efficacy and safety of nabilone in this patient group is warranted.","is_dataset_classified":null,"base_score":1.791759469228055,"endowment":1.791759469228055,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"19162232","pmcid":null,"openalex_id":"https://openalex.org/W2896232408","authors":[],"funders":[],"total_grants":0,"fwci":0.7542,"citation_percentile":0.70950469,"influential_citations":0,"citation_trend":[{"year":2019,"count":2},{"year":2020,"count":2},{"year":2021,"count":1}],"oa_status":"closed","license":null,"oa_locations":[{"url":"https://doi.org/10.1016/j.jalz.2018.06.2871","host_type":"journal"}],"fields_of_study":["Attention Deficit Hyperactivity Disorder"],"mesh_terms":[],"keywords":["Clinical Global Impression","Placebo","Medicine","Randomized controlled trial","Psychomotor agitation","Internal medicine","Dementia","Psychiatry","Disease"],"sdg_mappings":[],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-10T03:11:18.426600Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}