BOSTON--(BUSINESS WIRE)--Cerveau Technologies, Inc. today announced 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 (DS). 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 organization 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. “There is a major need to research AD within the context of DS, and to apply the latest technologies and biomarkers, such as MK-6240, for this population. Our vision for Alzheimer’s in Down syndrome is to lead a collaborative effort to enable rapid enrollment of large Alzheimer’s clinical trials in Down syndrome by 2020. Our organization works tirelessly with participants, families, clinicians, collaborators and sponsors to deliver on this vision,” said Hillerstrom.
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 (PET) scans for assessing the status and progression of neurofibrillary tangles (NFTs) 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 welcomes this opportunity to work with LuMind IDSC and researchers in the medical community to understand the application of MK-6240 and how it may benefit patients with Down syndrome and interrelated disease. Our collaboration with LuMind IDSC will support multiple projects over the next several years and enable Cerveau to provide LuMind IDSC’s researchers and partners access to the MK-6240 tracer in support of various trials, as well as facilitate novel academic research, evaluating potential treatment options for adults with Down syndrome.” said Rick Hiatt, President and CEO of Cerveau Technologies, Inc.
“Tau PET imaging is an exciting emerging technology that may help our understanding of the progression of Alzheimer’s disease in adults with Down syndrome. LuMind IDSC is excited to work with Cerveau to bring brain imaging to the DS-CTN network and LIFE-DSR study,” adds James Hendrix, Chief Scientific Officer of LuMind IDSC.
About Cerveau Technologies, Inc.
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.
About LuMind IDSC
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.