Abstract Details

OVERTURE RCT, a 6-month Phase 2 trial evaluated the feasibility, safety, efficacy, and adherence of Cognito’s non-invasive medical device as a novel therapeutic intervention for mild and moderate AD participants. OVERTURE OLE, a 12-month extension evaluated the durability of OVERTURE RCT results.

To examine total, basic, and instrumental activities of daily living change from baseline, in mild and moderate Alzheimer’s disease (AD) participants in OVERTURE RCT (NCT03556280) and OVERTURE Open Label Extension (OLE).

135 Mild/moderate AD participants were screened, and 76 were randomized (2:1) to receive daily, one-hour, EEG-calibrated, active or sham treatment in a 6-month duration trial (OVERTURE RCT) using Cognito’s non-invasive medical device, 74 were treated and 53 completed the trial. 44 out of 53 (83%) participants entered the OLE, and 22 participants completed the evaluations at Month 18. 

In OVERTURE RCT, over a six-month period, consistent preservation of function was observed – Comparing Active treatment with Sham, Total ADCS-ADL, Basic-ADL, and Instrumental-ADL scores had 77%, 81%, and 78% less decline. Consistent changes across 23 ADCS-ADL items were observed in the RCT. Based on the Total ADCS-ADL, statistically significant separation between Active and Sham treatment was observed at the end of RCT (p=0.0006), and the separation between Active treatment and Sham switch to active treatment was maintained after 12 months in the OLE (p=0.0045), reinforcing OVERTURE RCT results and, consistent with criteria for disease modification. Device adherence in OVERTURE RCT and OLE was high (≥80%) and the treatment was safe and well tolerated.

Activities of daily living (ADCS-ADL) outcomes observed in OVERTURE RCT carry over through OVERTURE OLE, reinforcing Cognito therapy’s durability and consistency of impact on functional outcomes for mild and moderate AD participants.