Safety, efficacy, and feasibility of intranasal insulin for the treatment of mild cognitive impairment and Alzheimer disease dementia: A randomized clinical trial
JAMA Sep 18, 2020
Craft S, Raman R, Chow TW, et al. - In a phase 2/3 multisite clinical trial involving 289 candidates (155 men [54.6%]; mean [SD] age, 70.9 [7.1] years), researchers sought to investigate the feasibility, safety, and effectiveness of intranasal insulin for the treatment of persons with mild cognitive impairment and Alzheimer disease dementia. Between 2014 and 2018, a randomized (1:1) double-blind clinical trial was performed. During the blinded phase, participants received 40 IU of insulin or placebo for 12 months, followed by a 6-month open-label extension phase. According to results, no cognitive or functional benefits in the primary intention-to-treat cohort were identified with intranasal insulin treatment over a 12-month period. No clinically relevant adverse effects were associated with treatment.
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