Cognito Therapeutics has reached its enrolment goal for the randomised, sham-controlled HOPE Study investigating the Spectris AD system鈥檚 efficacy and safety in treating Alzheimer’s disease.
The double-blind trial, with 670 subjects enrolled, is set to use the company鈥檚 neuromodulating device at home for 12 months.
Carried out across 70 US clinical sites, the trial will be followed by a 12-month open-label extension trial.
According to the company, the Spectris AD system will deliver synchronised light and sound stimulation at the 40Hz gamma frequency, which has previously shown promise in the OVERTURE feasibility study by preserving corpus callosum structure in subjects with Alzheimer’s.
Results from the study indicated a 76% and 77% decrease in cognitive and functional decline, respectively, and significant white matter preservation with a 69% decrease in whole brain atrophy over six months.
Subjects in the HOPE Study鈥檚 treatment group will receive Active Sensory Stimulation System treatment once a day while the control group will use a Sham Sensory Stimulation System.
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By GlobalDataStudy visits for consent, screening, and baseline assessments are scheduled, followed by three, six, nine (by phone), 12, and 13 months safety follow-ups.
The primary aim of the study is to evaluate Spectris’ efficacy in slowing Alzheimer’s progression against sham for mild to moderate patients, measured functionally by the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) assessment and the Mini-Mental State Exam (MMSE).
A subset of clinical sites will participate in a substudy to assess additional fluid biomarkers.
Subjects at these sites will undergo lumbar punctures to collect cerebrospinal fluid at baseline, three months, and 12 months.
Cognito Therapeutics CEO Christian Howell said: 鈥淐ompleting enrolment in this landmark trial marks a major step forward in our mission to deliver a better treatment option for people living with neurodegenerative conditions such as Alzheimer鈥檚.鈥�
The system remains investigational and is not yet available for sale.
In 2023, Cognito secured $73m in Series B funding to further develop its wearable neuromodulation device for Alzheimer鈥檚.
