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Cranial Device for Alzheimer's Disease
Lane Simonian
Posted: Tuesday, January 26, 2021 9:55 AM
Joined: 12/12/2011
Posts: 4983


The FDA has granted breakthrough status for a head device for the potential treatment of Alzheimer's disease.  It will be interesting to see what the larger study reveals.

https://www.bioworld.com/articles/499532-fda-bestows-breakthrough-status-on-neuroem-therapeutics-alzheimers-therapy




Lane Simonian
Posted: Thursday, March 11, 2021 11:45 AM
Joined: 12/12/2011
Posts: 4983


There is still a long ways to go, but this is starting to get interesting:

Cognito Therapeutics touts positive Phase 2 results for device-delivered Alzheimer's treatment

 
The startup will now move onto a larger pivotal trial of the neuromodulation therapy, which received a Breakthrough Device Designation from the FDA in January.

The OVERTURE study, a multi-center, randomized controlled trial, enrolled 76 such patients aged 50 years or older beginning in 2018. These participants were randomized to receive either Cognito's audio-visual stimulation treatment or a sham stimulation for one hour each day in their home.

Throughout the six-month treatment period, Cognito said the treatment group (n = 33) compared to the placebo group (n =20) demonstrated a significant 84% slowdown in functional decline and a significant 83% decline in cognitive impairment, as measured using standardized scales every four weeks. In addition, there was a significant 61% reduction in whole brain atrophy and volumetric loss among 30 treatment group participants in comparison to 19 placebo group participants, according to the company.

 

https://www.mobihealthnews.com/news/cognito-therapeutics-touts-positive-phase-2-results-device-delivered-alzheimers-treatment