Joined: 2/17/2019 Posts: 347
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Detailed Description {if you were waiting for advances in bio-science...}
Participants will
receive an intravenous infusion of either GRF6019, ( a human plasma protein fraction) or placebo every day
for 5 days in a row. The total study duration is approximately 9 weeks.
Locations
Name
City
State
Zip
Status
Primary Contact
Cognitive Clinical Trials
Gilbert
Arizona
85297
Recruiting
Brian Beck, MD brianbeck@cctresearch.com
Cognitive Clinical Trials
Mesa
Arizona
85209
Recruiting
Brian Beck, MD brianbeck@cctresearch.com
Cognitive Clinical Trials
Phoenix
Arizona
85037
Recruiting
Brian Beck, MD brianbeck@cctresearch.com
Pacific Research Network
San Diego
California
92103
Recruiting
Heidi Davis hdavis@cnssites.com
Riverside Clinical Research
Edgewater
Florida
32132
Recruiting
James Scott, MD pi14@interspond.com
Bio Behavioral Health
Toms River
New Jersey
08755
Recruiting
Ashok Patel, MD ap@bbhnj.com
Lead Sponsor Agency
Investigators
Name
Role
Affiliation
Alkahest Program Physician
Study Director
Alkahest, Inc.
Study Contact
Name
Phone
Email
Alkahest Clinical Trials
650-801-0474
trials@alkahest.com
Official Title:A Randomized, Double-Blind,
Placebo-Controlled Study to Assess the Safety and Tolerability of Pulsed
GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
Inclusion Criteria:
- Diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) Criteria
- MMSE Score 0-10 inclusive
- Modified Hachinski Ischemia Scale (MHIS) score of 4 or less
- Provided a signed and dated informed consent form (either the subject and/or subject's legal representative)
Ages Eligible for Study:
60 Years to 95 Years (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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Joined: 2/17/2019 Posts: 347
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Stories to fuel your mind.
Aging Is Reversible—at Least in Human Cells and Live Mice
Study shows changes to gene activity that occur with age can be turned back.
 Photo by Catherine Falls Commercial / Getty Images
.
Research suggests it is possible to slow or even reverse aging,
at least in mice, by undoing changes in gene activity—the same kinds of
changes that are caused by decades of life in humans.
https://getpocket.com/explore/item/aging-is-reversible-at-least-in-human-cells-and-live-mice?utm_source=pocket-newtab
By tweaking genes that turn adult cells back into
embryoniclike ones, researchers at the Salk Institute for Biological
Studies reversed the aging of mouse and human cells in vitro, extended
the life of a mouse with an accelerated-aging condition and successfully
promoted recovery from an injury in a middle-aged mouse, according to a
2016 study published in
Cell.
The
study adds weight to the scientific argument that aging is largely a
process of so-called epigenetic changes, alterations that make genes
more active or less so. Over the course of life cell-activity regulators
get added to or removed from genes. In humans those changes can be
caused by smoking, pollution or other environmental factors—which dial
the genes’ activities up or down. As these changes accumulate, our
muscles weaken, our minds slow down and we become more vulnerable to
diseases.
The
study suggests the possibility of reversing at least some of these
changes, a process researchers think they may eventually get to work in
living humans. “Aging is something plastic that we can manipulate,” says
Juan Carlos Izpisua Belmonte, the study’s senior author and an expert
in gene expression at Salk. In their study Belmonte and his colleagues
rejuvenated cells by turning on, for a short period of time, four genes
that have the capacity to convert adult cells back into an embryoniclike
state.
***
Other approaches that have been discovered to have
anti-aging benefits in animals include calorie restriction, the drug
rapamycin and parabiosis—the practice of giving old mice a blood supply
from younger ones. The fact that these diverse strategies all seem to
work suggests there may be more than one way to age, and that multiple
complementary therapies may be needed to significantly extend longevity,
Kaeberlein says.
Some
compounds such as resveratrol, a substance found in red wine that seems
to have anti-aging properties in high concentrations, appear to delay
epigenetic change and protect against damage from epigenetic
deterioration, Sinclair says. These approaches can reverse some aspects
of aging, such as muscle degeneration—but aging returns when the
treatment stops, he adds.
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Joined: 2/17/2019 Posts: 347
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I am not sure if the Young Plasma Serum actually counts as stem cell technology but it sure sounds like it.....
A 9 Week IV trial attempts to repair age related alzheimer's damage with
" circulating factors found in the blood of
young people might address some of the neurodegenerative consequences of
AD or associated neurodegeneration".
The trial for people with mild to moderate Alzheimers ran from April 16, 2018 to May 24, 2019.
Conclusions and Relevance:
The yFFP treatment was safe, well
tolerated, and feasible. The study's limitations were the small sample
size, short duration, and change in study design. The results warrant
further exploration in larger, double-blinded placebo-controlled
clinical trials.
A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
Official Title:
A
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety
and Tolerability of Pulsed GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
Actual Study Start Date :
January 15, 2019
Estimated Primary Completion Date :
March 2020
Estimated Study Completion Date :
March 2020
Inclusion Criteria:
- Diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) Criteria
- MMSE Score 0-10 inclusive
- Modified Hachinski Ischemia Scale (MHIS) score of 4 or less
- Provided a signed and dated informed consent form (either the subject and/or subject's legal representative)
Ages Eligible for Study:
60 Years to 95 Years (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Trial for moderate is done. This trial Severe Alzheimer's Trial.
a human plasma protein fraction) or placebo every day for 5 days in a row. The total study duration is approximately 9 weeks
GRF6019 is
a proprietary plasma fraction of about 400 proteins, developed by
Alkahest and manufactured by Grifols. It represents a second-generation
product of earlier clinical research infusing young adult plasma to
treat age-related neurodegenerative disease (see Young Plasma).Nov 28, 2019
Nov 28, 2019 - GRF6019 is
a proprietary plasma fraction of about 400 proteins, developed by
Alkahest and manufactured by Grifols. It represents a second-generation
product of earlier clinical research infusing young adult plasma to
treat age-related neurodegenerative disease (see Young Plasma).
Young Plasma for an old Brain. Same trial, better title.
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