Neurostimulation device GammaSense by Cognito Therapeutics secures FDA Breakthrough Device Designation to explore Alzheimer’s Disease applications

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Cred­it: The Picow­er Insti­tute @ MIT

Cog­ni­to Ther­a­peu­tics nets FDA break­through label for light, sound ther­a­py for Alzheimer’s dis­ease (Fierce Biotech):

Using spe­cif­ic fre­quen­cies of flash­ing lights and sounds to stim­u­late the brain’s elec­tri­cal activ­i­ty, Cog­ni­to Ther­a­peu­tics believes it can help treat Alzheimer’s dis­ease by ener­giz­ing neu­rons and reac­ti­vat­ing the immune system.

Described as sim­i­lar to a strobe light, but much faster, Cognito’s Gam­maSense stim­u­la­tion sys­tem is built into a pair of opaque glass­es worn with a set of head­phones. The dai­ly treat­ment has shown pos­i­tive effects in mice, with changes in the brain’s hip­pocam­pus and audi­to­ry cor­tex includ­ing the reduc­tion of amy­loid plaques, accord­ing to a study pub­lished in Cell.

Now, with the treat­ment approach being stud­ied in place­bo-con­trolled human tri­als, the FDA said it has seen enough ear­ly clin­i­cal data to label the device as a poten­tial break­through therapy—affording the com­pa­ny pri­or­i­ty review and addi­tion­al oppor­tu­ni­ties to work with agency offi­cials through the project’s clin­i­cal and com­mer­cial development.

The Announcement:

Cog­ni­to Ther­a­peu­tics Receives FDA Break­through Device Des­ig­na­tion for Next-Gen­er­a­tion Dig­i­tal Ther­a­peu­tic in Alzheimer’s Dis­ease (press release):

Cog­ni­to Ther­a­peu­tics, a clin­i­cal-stage com­pa­ny lead­ing the devel­op­ment of a new class of dis­ease-mod­i­fy­ing dig­i­tal ther­a­peu­tics to treat neu­rode­gen­er­a­tive dis­or­ders, announced today its lead prod­uct has received Break­through Device Des­ig­na­tion from the U.S. Food and Drug Admin­is­tra­tion (FDA) for the treat­ment of cog­ni­tive and func­tion­al symp­toms asso­ci­at­ed with Alzheimer’s dis­ease. The prod­uct, a non-inva­sive neu­rostim­u­la­tion device using gam­ma fre­quen­cy tech­nol­o­gy, is the first in the Company’s pipeline of dig­i­tal ther­a­peu­tics for neu­rode­gen­er­a­tive dis­eases and oth­er chron­ic indications…

“I am encour­aged by Cognito’s inno­v­a­tive approach,” said Allan Lev­ey, M.D., Ph.D., Pro­fes­sor and Chair­man of the Depart­ment of Neu­rol­o­gy at Emory Uni­ver­si­ty and Direc­tor of the Emory Goizue­ta Alzheimer’s Dis­ease Research Cen­ter. “This strat­e­gy trans­lat­ing recent advances in non-inva­sive mod­u­la­tion of brain activ­i­ty with sen­so­ry stim­u­la­tion with light and sound has the poten­tial to be an urgent­ly need­ed safe, non-inva­sive, and effec­tive treat­ment for mil­lions of indi­vid­u­als with Alzheimer’s disease.”

The Study:

Mul­ti-sen­so­ry Gam­ma Stim­u­la­tion Ame­lio­rates Alzheimer’s‑Associated Pathol­o­gy and Improves Cog­ni­tion (Cell):

  • Abstract: We pre­vi­ous­ly report­ed that induc­ing gam­ma oscil­la­tions with a non-inva­sive light flick­er (gam­ma entrain­ment using sen­so­ry stim­u­lus or GENUS) impact­ed pathol­o­gy in the visu­al cor­tex of Alzheimer’s dis­ease mouse mod­els. Here, we designed audi­to­ry tone stim­u­la­tion that drove gam­ma fre­quen­cy neur­al activ­i­ty in audi­to­ry cor­tex (AC) and hip­pocam­pal CA1. Sev­en days of audi­to­ry GENUS improved spa­tial and recog­ni­tion mem­o­ry and reduced amy­loid in AC and hip­pocam­pus of 5XFAD mice. Changes in acti­va­tion respons­es were evi­dent in microglia, astro­cytes, and vas­cu­la­ture. Audi­to­ry GENUS also reduced phos­pho­ry­lat­ed tau in the P301S tauopa­thy mod­el. Fur­ther­more, com­bined audi­to­ry and visu­al GENUS, but not either alone, pro­duced microglial-clus­ter­ing respons­es, and decreased amy­loid in medi­al pre­frontal cor­tex. Whole brain analy­sis using SHIELD revealed wide­spread reduc­tion of amy­loid plaques through­out neo­cor­tex after mul­ti-sen­so­ry GENUS. Thus, GENUS can be achieved through mul­ti­ple sen­so­ry modal­i­ties with wide-rang­ing effects across mul­ti­ple brain areas to improve cog­ni­tive function.

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