Cognito Therapeutics initiates Down syndrome Alzheimer’s study

pharmafile | June 15, 2021 | News story | Manufacturing and Production  

Cognito Therapeutics are going to run a second digital therapeutic study evaluating individuals who have the genetic rare disease, Down syndrome associated Alzheimer’s Disease.

Around 50% or more people with Down syndrome will develop Alzheimer’s Disease.

Cognito conducted a patient research study with adults with Down syndrome to demonstrate proof-of-concept for a clinical study to show disease modification and patient improvement in this population.

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The study included in-home interviews with ten caregivers and 13 adults with Down syndrome, aged 32-61 years old. Roughly half of the participants with Down syndrome indicated having symptoms of cognitive decline associated with Alzheimer’s disease or had a confirmed diagnosis.

Results of the study showed that Cognito’s therapeutic intervention was well-tolerated by DS-AD patients and their caregivers, and that the DS-AD patients did not exhibit any adverse reactions.

DS-AD is a genetically associated, aggressive form of Alzheimer’s where individuals with Down syndrome are born with an extra copy of chromosome 21, which carries a gene that produces a specific protein called amyloid precursor protein (APP). Too much APP protein leads to a build-up of beta-amyloid plaques in the brain.

By age 40, most people with Down syndrome have amyloid plaques, along with other protein deposits, such as tau tangles.

Brent Vaughan, Chief Executive Officer of Cognito Therapeutics, said: “We’re excited to advance another disease-modifying therapeutic in our pipeline, as current estimates suggest that 50% or more of people with Down syndrome will develop dementia due to Alzheimer’s disease.

“With no treatments currently indicated for Down syndrome-associated Alzheimer’s, new therapies are urgently needed for this patient population.

“Our team is using the results of this patient assessment study to inform future study design and address adaptations to our digital therapeutic platform to support adherence and improved outcomes for these patients. This new program in DS-AD will add to our robust pipeline focused on novel treatments for significant unmet medical needs in neurodegenerative conditions.”

One Medical Director from a national Medicare plan said: “I think it’s a breakthrough product that has a significant impact on the progression of mild to moderate Alzheimer’s disease in Down syndrome. I would expect that it will have similar efficacy in non-Down syndrome Alzheimer’s, which is a very major therapeutic breakthrough.”

This news comes shortly after a new controversial Alzheimer’s drug was approved by the FDA, which has led to several advisory panel members quitting in protest.

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