- A year of treatment with intranasal insulin did not slow cognitive decline in patients with amnestic mild cognitive impairment or Alzheimer disease, but drug delivery was initially problematic.
Why this matters
- Efficacious interventions for prevention and treatment of Alzheimer disease are lacking.
- Among patients treated with device 2, there was a nonsignificant difference between insulin and placebo groups on mean score change on Alzheimer Disease Assessment Scale-cognitive subscale 12 (ADAS-cog-12) at month 12 (0.0258 points; P=.98).
- Groups also had similar changes in:
- Clinical Dementia Rating scale Sum of Boxes.
- Activities of Daily Living Scale for Mild Cognitive Impairment.
- Memory composite test.
- Cerebrospinal fluid levels of Alzheimer disease biomarkers.
- No clinically important adverse events reported.
- US phase 2/3 multicenter randomized controlled trial among 289 older adults with amnestic mild cognitive impairment or Alzheimer disease:
- Score ≥20 on Mini-Mental State Examination.
- Clinical dementia rating 0.5 or 1.0.
- Delayed logical memory score.
- 12-month double-blind phase: daily insulin (40 IU) vs placebo.
- Intranasal delivery:
- 49 patients used device 1 (inconsistent reliability).
- 240 patients used device 2.
- Main outcome: mean score change on ADAS-cog-12.
- Funding: National Institute on Aging; Eli Lilly (provided diluent, insulin).
- Switch of devices midtrial.
- Device 2 not used previously in patients with Alzheimer disease.