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Clinical Studies

Clinical studies

We are committed to rigorous clinical research to demonstrate the safety and effectiveness of Spectris AD, our investigational treatment for mild-to-moderate Alzheimer’s disease.

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We have completed our OVERTURE feasibility study and fully enrolled our pivotal HOPE study. Patients across multiple clinical studies have completed over 100,000 treatment sessions to date.
OVERTURE Study
HOPE Study
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OVERTURE Study

OVERTURE was a randomized, sham-controlled, double-blind, multicenter 6-month feasibility study in 76 patients with mild-to-moderate Alzheimer’s disease.

Topline results
At 6 months, when compared to the control group, patients receiving treatment experienced:
77%
Reduction in decline of daily function as measured by ADCS-ADL (total)
76%
Reduction in decline of cognitive function as measured by MMSE
69%
Reduction in MRI brain volume loss
85%
Device adherence
Trial design

Our OVERTURE feasibility study treated both mild- and moderate Alzheimer’s participants (n=76) with a clinical presentation across the AD continuum (MMSE 14-26, inclusive). Patients were randomized 2:1 to receive daily, one-hour, non-invasive gamma therapy or sham treatment. For more information on study design and end points please visit clinicaltrials.gov/study/NCT03556280.

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Broad Alzheimer’s population
OVERTURE enrolled a broad group of Alzheimer’s patients ranging from mild to moderate severity. Patients were not required to have specific threshold values of amyloid as determined by positron-emission tomography (PET) or by cerebrospinal fluid testing, allowing more patients to have access to our trial.
Outcomes that matter
Measurement of daily function and cognition are highly relevant outcomes to AD patients and their caregivers and are related to measures of disease progression, including brain atrophy. It was equally important for us to assess the impact of our therapy on these important outcome measures through the assessments of both MMSE and ADCS-ADL.
Verified target engagement
Prior to enrollment, each patient’s response to our non-invasive therapy was confirmed through EEG, indicating target engagement of the therapeutic intervention. Intensity of the intervention was also tailored to each patient based on their tolerability.
a Patients were treated at home for 1 h/day with either the active device or the sham device.
b Of those who completed the blinded phase of the trial, 33 patients completed the blinded phase in the active device group and 20 patients completed the blinded phase in the sham device group.
User experience
The therapy was well tolerated by the subjects in the study and the average adherence across the subjects who completed the 6-month study was 85%. Adherence was calculated as the percentage of days in the study where the therapy was used for 45 minutes or more.
There were no unexpected device-related treatment limiting Serious Adverse Events (SAEs) and treatment related adverse events (TRAE) were generally mild and resolved.
Benefit/risk findings were maintained in the 12-month Open Label Extension (OLE).
Demonstrated effects
Preservation of cognition
Decline in cognition and function, two of the hallmark characteristics of Alzheimer’s disease, significantly impact the day-to-day lives of patients and their families.
Significant preservation of cognition over 6 months was observed. When compared to the control group, patients receiving treatment experienced 76% reduction (p<0.05) in cognitive decline measured by MMSE score.
Preservation of function
Patient function in Alzheimer’s disease is an important determinant of healthcare utilization, independence, and quality of life and is strongly linked to cognition and brain atrophy.2
Compared to the control group, patients receiving active treatment experienced 77% slowing of ADCS-ADL total score (p<0.001), a clinically accepted measure of patient function.
Preservation of brain volume
Brain atrophy, or brain volume loss, accelerates in Alzheimer’s disease and often declines in parallel with cognitive and functional decline. Brain atrophy is an important indicator of disease progression.
When compared to the control group, patients receiving active treatment experienced 69% slowing of brain atrophy or volume loss as measured by MRI (p<0.01).
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HOPE Study

The HOPE Study is a randomized pivotal trial investigating the safety and efficacy of Cognito’s treatment in mild-to-moderate Alzheimer’s Disease.

70
Investigational sites across the United States
673
Trial participants (fully enrolled)
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The HOPE Study offers a rare opportunity for patients with mild to moderate Alzheimer’s disease to participate in a research study utilizing technology as an intervention. Our patients and families have expressed great interest in enrolling in this study because it is non-invasive and represents a novel approach to potentially slowing the progression of Alzheimer’s disease.
Dr. Michelle Papka, Ph.D.
Director and Founder of The Cognitive and Research Center of New Jersey
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Citations
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‍1Hajos et al. (2024). Sensory gamma stimulation preserves functional and structural outcomes in mild-to-moderate Alzheimer’s disease: Results from the Overture clinical trial. Frontiers in Neurology, 15, 1343588.

2Jones RW, Lebrec J,Kahle-Wrobleski K, Dell'Agnello G, Bruno G, Vellas B, Argimon JM, Dodel R, Haro JM, Wimo A, Reed C. Disease Progression in Mild Dementia due to Alzheimer Disease in an 18-Month Observational Study (GERAS): The Impact on Costs and Caregiver Outcomes. Dement Geriatr Cogn Dis Extra. 2017 Mar 20;7(1):87-100.doi: 10.1159/000461577. PMID: 28611822; PMCID: PMC5465649.