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.
For more information about the LIFE DSR Study, visit www.ds-ctn.org/LIFE-DSR.
Learn more about Cerveau Technologies, Inc. at https://cerveautechnologies.com/.
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.
Contacts
Cerveau Technologies, Inc.
Rick Hiatt, 617-906-2715
RFhiatt@cerveautechnologies.com
LuMinds IDSC Foundation
Dr. Jim Hendrix, 781-825-1307
jhendrix@lumindrds.org