The company reported a reduced dependence score of 56.4% over 18 months in patients with mild to moderate Alzheimer’s, preserving patient function and potentially easing caregiver burden. The findings from the Phase 2 OVERTURE trial support Spectris as a promising option in Alzheimer’s treatment.
According to Cognito Therapeutics, the Alzheimer’s Disease Dependence Score is a 13-item scale derived from ADCS-ADL data that assesses the level of assistance patients require due to disease progression. It is closely linked with cognitive decline, caregiver burden, and healthcare costs.
Cognito’s Phase 2 OVERTURE trial assessed the efficacy of Spectris in a randomized controlled setting with a subsequent 12-month open-label extension. Of the 44 participants who completed the initial trial, 39 were evaluated at 9 months and 22 at 18 months. The results showed a 56.4% decrease in the Alzheimer’s Dependence Score in patients treated with Spectris compared to those who received a sham treatment, demonstrating statistical significance.
“Spectris demonstrates a meaningful reduction in dependence associated with Alzheimer’s disease, which not only reflects improved patient function but may also translate to decreased healthcare costs and caregiver time,” said Dr. Marwan Sabbagh, a neurologist in the Alzheimer’s and Memory Disorders Program at Barrow Neurological Institute. “The findings affirm our commitment to developing therapies that address the needs of patients and their families.”
Other findings from the trial
In the OVERTURE study, patients received Spectris showed a reduction in the Alzheimer’s Disease Dependence Score after 18 months with a share of +0.96 (95% CI: 0.47–1.44) from baseline, compared to +2.20 (95% CI: 1.17–3.24) in the sham group. Additionally, the treatment demonstrated a strong safety profile, with no reported cases of Amyloid Related Imaging Abnormalities (ARIA) or serious treatment-related adverse events during the open-label extension phase.
Cognito Therapeutics highlighted its efforts toward diversity in clinical research through its Phase 3 HOPE study, which aims to better reflect the demographics of Alzheimer’s patients. The study has enrolled 467 participants to date, with a breakdown of 88.7% white, 9.0% Black or African American, 1.7% Asian, 0.6% identifying as other, and 5.6% identifying as Hispanic or Latino.
“Diversity in clinical trials is crucial for the development of therapies that can be generalized across representative patient populations,” Chief Medical Officer Ralph Kern said in a news release. “Our collaboration with the Global Alzheimer’s Platform Foundation (GAP) has enabled us to implement targeted recruitment strategies to enhance participation of underrepresented groups.”
The HOPE study uses GAP’s geographically targeted site selection and diversity, equity and inclusion training for site staff, focusing on culturally competent outreach. Cognito Therapeutics is actively enrolling patients for the HOPE pivotal trial. Further information on the study can be found at www.hopestudyforad.com.
