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• W2980993503 abstract "Insulin modulates many aspects of brain function relevant to AD, and can be delivered to the brain using intranasal devices. Intranasal insulin enhanced memory in small, single-site studies of MCI and AD. Twenty-six sites enrolled 289 participants with MCI or AD (NIA-AA criteria). Participants were randomized (1:1) to receive 40-IU of placebo or insulin (Humulin-RU100, Eli Lilly) daily for 12-months followed by a 6-month open-label extension (OLE). Outcomes included the AD Assessment Scale for Cognition-12 (ADASCog12/primary, month-15 and -18), and the Activities of Daily Living Scale for MCI (ADL-MCI). For the first 49 participants, the device (Kurve Technology) had inconsistent reliability, leading to a decision to seek a substitute. A new device (Impel NeuroPharma) was used for the remaining 240 participants. The Impel cohort was pre-specified for the primary intent-to-treat (ITT) analyses, while secondary analyses examined the Kurve ITT cohort. Mixed model repeated measures analysis showed no effects of insulin compared with placebo for mean change in ADASCog12 score at 12-months for the Impel cohort, whereas the Kurve cohort showed a trend for better performance for the insulin group (p=0.091). The present analyses examine OLE results for both cohorts. 203 of 240 Impel participants and 44 of 49 Kurve participants entered the OLE. There were no demographic differences between participants originally randomized to insulin (early-start) or placebo (delayed-start). For the Impel cohort, early- and delayed-start groups did not differ on the ADASCog12 or other outcomes. The early-start Kurve cohort had better ADASCog12 scores at months-15 and -18 (−5.70 and −5.78 points, nominal ps=0.004 and 0.018) than did delayed-start participants, and better ADL-MCI scores (month-18, 4.85 points, nominal p=0.047). Compliance and adverse events were similar for early- and delayed-start groups for both cohorts. No differences were observed for the primary OL analyses with the Impel cohort. For the Kurve cohort, trends observed in the blinded phase strengthened, resulting in better ADASCog12 performance for the early-start group. Differences in the devices’ ability to deliver insulin may have contributed to this pattern. Further investigation is needed to confirm possible beneficial effects of intranasal insulin for AD." @default.
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• W2980993503 date "2019-07-01" @default.
• W2980993503 modified "2023-09-27" @default.
• W2980993503 title "DT-02-03: OPEN LABEL EXTENSION RESULTS FROM A PHASE II/III TRIAL OF INTRANASAL INSULIN" @default.
• W2980993503 doi "https://doi.org/10.1016/j.jalz.2019.08.012" @default.
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