Policy & Regulation
Cerveau Technologies Forges Partnership with LuMind IDSC Foundation to Study Accumulation of Neurofibrillary Tau in Down Syndrome
15 May 2019 - - US-based diagnostics developer Cerveau Technologies, Inc. has inked a research collaboration with the LuMind IDSC Foundation (LuMind IDSC) involving use of Cerveau's investigational imaging agent (MK-6240) in a multicenter clinical trial aimed at assessing accumulation of misfolded tau protein in people with Down syndrome, the company said.

The trial will be conducted as a sub-study of the LuMind IDSC's LIFE-DSR natural history study, the first study in the Down Syndrome Clinical Trials Network (DS-CTN).

LuMind IDSC is a Boston-based non-profit organisation that envisions a world where every person with Down syndrome thrives with improved health, independence, and opportunities to reach their fullest potential.

LuMind IDSC accelerates research to increase availability of therapeutic, diagnostic, and medical care options and empowers families through education, connections, and support.

In the fall of 2018, the Foundation launched the first Down Syndrome Clinical Trials Network (DS-CTN) including 11 sites that will conduct large, multi-site trials in 9 states focused on the prevention of Alzheimer's onset in people with Down syndrome.

Enrollment for the LIFE-DSR natural history study is expected to begin at the end of May 2019.

According to Hampus Hillerstrom, president and CEO of LuMind IDSC, by age 55–60 years at least 70% of adults with Down syndrome will develop Alzheimer's dementia.

The LIFE-DSR study is an observational investigation of adults with Down syndrome age 25 and over with the goal to better understand the cognitive and behavioral changes along with the health issues as they progress toward Alzheimer's disease.

The trial will use Cerveau's [F-18]MK-6240, an investigational imaging agent to be used in Positron Emission Tomography scans for assessing the status and progression of neurofibrillary tangles in the brain.

MK-6240 will assess the presence and extent of tau pathology longitudinally with two (2) scans, the first at enrollment and again after twelve months.

Relationship between tau burden as determined by imaging and cognitive state of participants will be assessed, as will any increase in the burden and any associated changes in neurological status.

NFTs made up of aggregated tau protein are a hallmark of several neurodegenerative diseases, including Alzheimer's disease.

By tracking tau tangles in the brains of people with DS, the LuMind IDSC/Cerveau collaboration may help further validate this marker as an effective surrogate for disease progression to facilitate improved understanding of AD process and drug development as outlined in recent publications.

Cerveau Technologies, Inc. is a partnership between Enigma Biomedical Group, Inc. and Sinotau Pharmaceutical Group. Cerveau's vision is to globally develop diagnostics and technology that positively impact patients with neurodegenerative disorders including Alzheimer's disease.

The LuMind IDSC Foundation (LuMind IDSC) is a Boston-based, international nonprofit organization founded in 2004 that envisions a world where every person with Down syndrome thrives with improved health, independence, and opportunities to reach their fullest potential. LuMind IDSC accelerates research to increase availability of therapeutic, diagnostic and medical care options and empowers families through education, connections and support.

The Foundation supports and catalyzes groundbreaking translational research projects at top academic institutions and industry companies. LuMind IDSC is also the largest online Down syndrome community providing a safe forum for parents and families throughout the lifespan to find peer-to-peer support, evidence-based research information and acceptance.
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