Clinical Studies

Clinical studies

We are committed to rigorous clinical research to demonstrate the effectiveness of our treatment.

We have successfully completed our Phase 2 OVERTURE study and are currently recruiting for our pivotal HOPE study. Patients across multiple clinical studies have completed over 40,000 treatment sessions to date.

OVERTURE Study

HOPE Study

OVERTURE Study

OVERTURE was a randomized, sham-controlled, double-blind, multicenter 6-month Phase 2 trial.

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

Zero

Cases of ARIA, unanticipated adverse device effects, or serious treatment-limiting adverse events reported

85%

Device adherence

Trial design

Our Phase 2 OVERTURE trial treated both mild- and moderate Alzheimer’s participants (n=74) with a clinical presentation across the AD continuum (MMSE 14-26, inclusive). Patients were randomized 2:1 to received 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. Unlike other clinical trials in AD, 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.

Safety & adherence

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 reports of amyloid-related imaging abnormalities (ARIA).

There were not treatment limiting Serious Adverse Events (SAEs) and Treatment related adverse events (TRAE) were generally mild and resolved.

Safety findings were confirmed in the 12 month Open Label Extension (OLE).

Efficacy

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.^a

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 declines in parallel with cognitive and functional decline. Brain atrophy is an important indicator of disease progression.^b

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).

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.

Investigational sites across the United States

500+

Trial participants

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

^b Fox NC, Scahill RI, Crum WR,Rossor MN. Correlation between rates of brain atrophy and cognitive decline inAD. Neurology. 1999 May 12;52(8):1687-9. doi: 10.1212/wnl.52.8.1687. PMID:10331700