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GRF6019 Trials for Severe AD in Gilbert, Mesa, Phoenix AZ, SanDiego, Edgewater FL, Toms River NJ
HowDoYouDeal
Posted: Sunday, November 10, 2019 9:13 PM
Joined: 2/17/2019
Posts: 348


 

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

Alkahest, Inc.

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  

ClinicalTrials.gov ID:NCT03765762

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

Criteria

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

HowDoYouDeal
Posted: Monday, December 30, 2019 11:18 AM
Joined: 2/17/2019
Posts: 348






 
GettyImages-1006201592.jpg

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.


HowDoYouDeal
Posted: Thursday, January 2, 2020 8:40 PM
Joined: 2/17/2019
Posts: 348


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

Criteria

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.

A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease

https://www.clinicaltrials.gov/ct2/show/NCT03765762