[P4–003]: A RANDOMIZED, PLACEBO‐CONTROLLED, CROSS‐OVER TRIAL INVESTIGATING NABILONE AS A TREATMENT FOR AGITATION IN PATIENTS WITH MODERATE‐TO‐SEVERE ALZHEIMER'S DISEASE: BLINDED, INTERIM SAFETY RESULTS
Bibliographic record
Abstract
Current pharmacological recommendations for the management of agitation in Alzheimer's disease (AD) include antipsychotics despite their modest benefits and high risk-profiles. Nabilone, a synthetic cannabinoid, has a distinct pharmacological profile, providing a safer and more effective alternative to treat agitation, while having benefits for weight and pain. We describe a clinical trial to investigate the safety and efficacy of nabilone in patients with moderate-to-severe AD. This is a double-blind, cross-over randomized placebo controlled trial comparing 6 weeks of nabilone (0.5–2mg) to 6 weeks of placebo, with a 1-week washout preceding each treatment phase. The recruitment goal is to randomize 40 patients over 2 years. The primary outcome is agitation, as measured by the Cohen-Mansfield Agitation Inventory (CMAI). The secondary outcomes includes behaviour (Neuropsychiatric Inventory (NPI)-NH), cognition (standardized Mini Mental Status Exam (sMMSE) and Severe Impairment Battery (SIB)) and global impression (Clinician's Global Impression of Change (CGI-C)). Exploratory outcomes include pain (Pain Assessment in Advanced AD (PAIN-AD)), nutritional status (Mini-Nutritional Assessment-Short Form (MNA-SF)), and safety. To date, twenty-three participants (mean±SD age=86.5±11.2, CMAI=68.4±19.4, NPI-NH total=33.1±14.6, sMMSE=5.9±5.5, SIB=39±28.9, PAIN-AD=2.9±1.5, MNA-SF=7.9±2.7, 69.6% male) have been randomized. Medication history includes a mean±SD of 12.2±5.5 concomitant medications and 1.8±0.8 psychotropic medications per participant. The mean±SD number of adverse drug reactions (ADRs) per participant was 1.7±1.1, with 22% of participants discontinuing due to ADRs. Sedation was experienced by 48% of participants in one phase of the study, with three participants experiencing treatment-limiting sedation. Preliminary data support that we are targeting an appropriate participant group given the participants’ age, clinical characteristics, concomitant medication use, and severity of neuropsychiatric symptoms. If positive, the findings of this study will provide a rationale for the feasibility of a larger, multicentre trial. Additionally, a safe and efficacious pharmacological intervention for agitation, pain and weight loss in patients with moderate-to-severe AD could increase quality-of-life, reduce caregiver stress and avoid unnecessary institutionalization and related increases in health-care costs.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.013 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".