The Effect of Nabilone on Neuropsychiatric Symptoms in Alzheimer's Disease: A secondary analysis
Bibliographic record
Abstract
BACKGROUND: Neuropsychiatric symptoms (NPS) are prominent in moderate-severe Alzheimer's disease (AD), and are associated with poor quality of life, early institutionalization and caregiver distress. Nabilone showed promising results as an agitation treatment in the 14-week Safety and Efficacy of Nabilone in Alzheimer's Disease trial, a randomized placebo-controlled trial in moderate-severe AD patients. We explored the treatment effects of nabilone on NPS other than agitation in the trial. METHOD: The trial included participants with Major Neurocognitive Disorder due to AD (Diagnostic and Statistical Manual-5 criteria), scored ≤24 on the Standardized Mini-Mental State Examination, and had clinically significant agitation (Neuropsychiatric Inventory-Nursing Home version (NPI-NH)-Agitation/Aggression (A/A) ≥3). It was a randomized crossover trial with 6-week treatment phases for nabilone and placebo, and a 1-week placebo washout period. NPI-NH was assessed at the start and the end of each treatment phase. Linear mixed models were fitted to compare the between-treatment phases for the change in each non-agitation NPI-NH sub-scale, except delusions/hallucinations, which was a trial exclusion criterion. The models included treatments (2 levels: nabilone and placebo) and baseline scores as fixed factors, and a random factor of participant code accounting for individual variability. RESULT: Thirty-nine participants with agitation (mean (SD) NPI-NH-A/A: 7.0 (3.2)) were recruited (77% male, age: 87 (10), nabilone dose: 1.6 (0.5) mg orally daily). There were greater decreases in anxiety (b=-1.12, SE=0.55, p = 0.048) and depression (b=-0.68, SE=0.31, p = 0.039) and greater changes in appetite/eating habits (b=2.00, SE=0.55, p < .001) observed during nabilone compared to placebo. Baseline scores (BL) for anxiety (BL nabilone/placebo: 4.6 (4.6)/4.6 (4.5), b=-0.32, SE=0.08, p < .001), depression (BL nabilone/placebo: 1.0 (3.0)/2.0 (3.0), b=-0.15, SE=0.06, p = 0.021), and appetite/eating habits (BL nabilone/placebo: 2.8 (3.7)/2.5 (3.6), b=-0.32, SE=0.08, p < .001) were significant predictors of the change in respective sub-scale scores, with higher baseline scores predicting a greater score decrease in treatment phases. CONCLUSION: In addition to the efficacy for improving agitation shown previously, these exploratory results suggest that nabilone can also alleviate anxiety and depression symptoms in moderate-severe AD patients. The change in appetite/eating habits required further attention, as the specific changes (increase or decrease in appetite) were unclear.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.009 | 0.011 |
| Meta-epidemiology (narrow) | 0.002 | 0.000 |
| Meta-epidemiology (broad) | 0.006 | 0.013 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
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".