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Brain Shrink reduced by 61%, Cog Decline by 84 % Flicker, Etude and Overture Results are In
Posted: Saturday, April 3, 2021 12:55 PM
Joined: 2/17/2019
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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.
By Dave Muoio
02:25 pm
A nerve cell affected by Alzheimer's disease

Yesterday Cognito Therapeutics, a startup using visual and auditory stimulation to treat neurodegenerative disorders, announced Phase 2 trial results suggesting its gamma frequency neuromodulation therapy slowed declines in memory and cognition among mild-to-moderate Alzheimer's disease patients.

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.

Flicker, the earlier study

Results from FLICKER, a 10-patient Phase 2 study, assessed the safety and tolerability of the digital therapeutic in patients with mild cognitive impairment due to AD. Patients in this study were assigned to one of two groups. The sham group did not receive therapy for four weeks, followed by gamma neuromodulation therapy, one-hour daily for four weeks. The treatment group received one-hour daily therapy for eight weeks. Results showed the therapy was safe, with no reported severe adverse events, with participants showing a high tolerance to the treatment. The study adherence rate was 95.5%, with 90% of patients volunteering to continue participation in an open-label extension study.

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Non-invasive Neurostimulation Device Wins FDA’s Breakthrough Status

Non-invasive Neurostimulation Device Wins FDA’s Breakthrough Status