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Archive for the ‘ Alzheimer’s Disease ’ Category

Alzheimer’s Research Announced in New London

Thursday, October 8th, 2020

New LUCIDITY clinical study to investigate potential treatment for people with Alzheimer’s disease

New London, October 2020- Coastal Connecticut Research has announced the start of patient recruitment for the LUCIDITY study (NCT03446001), a new clinical research study to evaluate an investigational drug in people who are experiencing memory loss, or have been diagnosed with Mild Cognitive Impairment (MCI or MCI-AD), Probable/Early Alzheimer’s disease (AD) or Mild-Moderate AD.

Dr. Laurence Radin will be serving as Principal Investigator of the study. He has served as the study doctor on over 10 clinical research trials for Alzheimer’s disease at Coastal Connecticut Research supported by a team of sub-investigators.

Although it is often accepted that some degree of forgetfulness is a natural part of the aging process, more severe memory loss – especially that which impacts daily life – could be an early sign of AD. Up to one third of people with MCI will go on to develop dementia,1 which affects around 50 million people worldwide.2

Currently, a limited number of approved treatments help with the symptoms of AD, but do not stop the disease from progressing.3 There are many factors and underlying challenges that contribute to the difficulty of developing new treatment options.3 However, rapid advances in our understanding of the underlying causes and risk factors associated with AD have led to new therapeutic targets and approaches.

Recent evidence suggests that Tau tangles are a potential driver in the progressive dementia that characterizes AD .4,5 Tau is a protein that forms part of a brain cell’s structure called a ‘microtubule.’ The microtubule helps transport nutrients within the brain cell and stabilizes the axons (a portion of a nerve cell) that connect one brain cell to another. In people with AD, Tau proteins do not function properly and form tangles inside the brain cells. This leads to a breakdown in the brain cell’s ability to communicate with other brain cells, which causes the symptoms of AD.6

Following nearly 30 years of research, researchers believe that a second-generation Tau aggregation inhibitor (TAI) could reduce the build-up of Tau tangles, and in doing so, could help slow disease progression and enhance quality of life for people with AD. Previous Phase 3 clinical trials (NCT01689233 and NCT01689246) support the possibility that this investigational treatment could be effective as a monotherapy, at a dose as low as 4 mg twice daily.7,8

Principal Investigator Dr. Laurence Radin said: “It is crucial we continue to research new targets and treatment options for Alzheimer’s disease. We are pleased to support the roll-out of the LUCIDITY study in Southeastern Connecticut, of which the results have the potential to provide renewed hope for the many people affected by this devastating disease.”

The LUCIDITY study, sponsored by TauRx Therapeutics Ltd. (“TauRx”), will evaluate the effects of this treatment in slowing or delaying memory loss in people who are not receiving other approved treatments for AD (cholinesterase inhibitors and/or memantine). Approximately 450 people in more than 100 study centers across North America and Europe are expected to take part in this study. The results of the study will help determine whether the investigational drug should progress to the final stages of clinical development.

Professor Claude Wischik, Executive Chairman and Co-Founder of TauRx, comments: “With no current cure and an aging population, Alzheimer’s disease is a pressing societal concern and there is an urgent need for new solutions. Our drug, an oral second-generation TAI, has already demonstrated encouraging signals in terms of efficacy and safety in previous trials, to the extent that it warrants further investigation. It’s our aim to find innovative and lasting solutions for patients living with Alzheimer’s disease, and we believe that Tau aggregation inhibition could be part of that solution.”

To learn more about the LUCIDITY study and to find out if you are eligible to participate, visit the trial website: LUCIDITYtrial.com or call Coastal Connecticut Research at (860)443-4567.  Information is also available at ccrstudies.com.

About Alzheimer’s disease

Alzheimer’s disease (AD) is a progressive neurologic disease of the brain that causes damage to neurons – the specialized cells of the nervous system that enable the flow of information, thoughts and memories in the brain. When Alzheimer’s damages neurons it leads to loss of memory and reasoning, which can affect a person’s ability to interact socially or function at work. No treatment yet exists to halt the progression of Alzheimer’s-related dementia, delay its onset, or prevent it from occurring. Currently available drugs only treat the symptoms temporarily.

Tau aggregation inhibitors

TauRx’s Tau aggregation inhibitors (TAIs) have arisen from nearly 30 years of research, preclinical and clinical investigations. TAIs work by undoing the Tau tangles that cause dementia, thereby potentially slowing and even arresting memory loss. The first-generation TAI, rember® was a patented, highly-purified version of methylthioninium chloride (methylene blue), a compound previously used to treat a variety of conditions.

About the LUCIDITY Study

LUCIDITY is a two-phase outpatient study with Phase 1 being a randomized, double-blind, placebo-controlled, 3-arm, 52-week safety and efficacy study and Phase 2 being an open-label, delayed start study, of an investigational drug in patients with Mild Cognitive Impairment (MCI or MCI-AD), or Probable/Early or Mild-Moderate Alzheimer’s disease. The primary objective of the LUCIDITY study is to demonstrate that the investigational treatment, given as a monotherapy at doses of 8 mg/day and 16mg/day, is effective compared to placebo in delaying the pathological and clinical progression of the disease. This will be measured using standard clinical cognitive and functional assessments; the study is expected to last up to 120 weeks for individual participants. LUCIDITY is now recruiting in sites across the United States, Canada, UK, France, Belgium, Italy, Spain and Poland. For further information, please visit: www.LUCIDITYtrial.com.

About Site

Coastal Connecticut Research in New London has partnered with community volunteers for over 20 years in conducting healthcare clinical research.  The site was founded by Dr. Robert M. Spitz who also serves as Medical Director.  In their two-decade history, 20 medications evaluated by community volunteers have gained FDA approval.

References

  1. Mavrodaris A, et al. Prevalences of dementia and cognitive impairment among older people in sub-Saharan Africa: a systematic review. Bull World Health Organ 2013, 91:773–783.
  2. World Health Organization. 2016 Dementia Fact Sheet. Available at: http://www.who.int/mediacentre/factsheets/fs362/en/ Accessed February 2019.
  3. Alzheimer’s Association. 2018 Alzheimer’s Disease Facts and Figures. Available at: https://alz.org/media/HomeOffice/Facts%20and%20Figures/facts-and-figures.pdf Accessed February 2019.
  4. Simić G, et al. Tau protein hyperphosphorylation and aggregation in Alzheimer’s disease and other tauopathies, and possible neuroprotective strategies. Biomolecules 2016, 6(1):6.
  5. Iqbal K, et al. Tau pathology in Alzheimer disease and other tauopathies. Biochim Biophys 2005, 1739(2-3):198–210.
  6. National Institute of Ageing. 2008 Alzheimer’s disease: Unravelling the mystery. Available at: https://adrccares.org/wp-content/uploads/2016/01/alzheimers_disease_unraveling_the_mystery_0.pdf Accessed February 2019.
  7. Gauthier S, et al. Efficacy and safety of tau-aggregation inhibitor therapy in patients with mild or moderate Alzheimer’s disease: a randomised, controlled, double-blind, parallel-arm, phase 3 trial. The Lancet 2016, 388:2873-84.
  8. Wilcock GK, et al. Potential of Low Dose Leuco-Methylthioninium Bis (Hydromethanesulphonate) (LMTM) Monotherapy for Treatment of Mild Alzheimer’s Disease: Cohort Analysis as Modified Primary Outcome in a Phase III Clinical Trial. Journal of Alzheimer’s Disease 2017, 61:435-457.

Media contacts:

MaryLou Gannotti

Email: marylou@ccrstudies.com

Call: (860)437-7092

Visit online: www.CCRstudies.com

LUCIDITY study website: LUCIDITYtrial.com

TauRx website: http://www.taurx.com

 

The Future of AD Research

Wednesday, September 30th, 2020

The LUCIDITY Study: A Clinical Research Study for People with Alzheimer’s disease.

Currently, a limited number of approved treatments help with the symptoms of AD, but do not stop the disease from progressing.  By reducing the build-up of ‘tau tangles,’ researchers believe that the investigational drug in this study could help slow disease progression and enhance quality of life for people with AD. The results of the LUCIDITY Study will help determine whether the investigational drug can progress to the final stages of clinical development.

The aim of the LUCIDITY Study is to assess the safety and effectiveness of an investigational drug in men and women with early to mild-moderate AD. Different doses of the investigational drug will be compared with a placebo, which looks similar to the investigational drug but contains non of its active ingredient.  Approximately 450 people in over 100 study centers across the United States, Canada, UK, France, Belgium, Italy, Spain and Poland are expected to take part.

You or a loved one may be eligible to participate in LUCIDITY if you:

  • Are under 90 years of age
  • Are experiencing memory loss, or have been diagnosed with
    • MCI (Mild Cognitive Impairment)/MCI-AD, or
    • Probable or Early Alzheimer’s disease
    • Mild-moderate Alzheimer’s disease
  • Have a study partner who can assist you with your participation

You can learn more about the LUCIDITY study by visiting http://LUCIDITYtrial.com. 

Difficult Behavior with Alzheimer’s

Monday, September 10th, 2018

Caring for a loved one with Alzheimer’s requires a tremendous amount of time, energy, patience, empathy and compassion.  But what happens to the caregiver when their loved one becomes abusive, verbally combative, and generally difficult?

Alzheimer’s disease does not just encompass memory loss.  Many of those living with Alzheimer’s will also develop agitation.  This difficult behavior can include repetition, mood swings, verbal combativeness, resistance, hitting, spitting and throwing things.  Some caregivers find themselves being hit or swung at.  Pacing and aimless wandering may occur, rocking, pointing fingers, and overall restlessness can make for a tremendous amount of stress and tension in addition to the other already difficult scenarios Alzheimer’s can present.

Over half of those living with Alzheimer’s will develop agitation.  This behavior may seem out of character and extreme but is not uncommon.  These symptoms can be a sign the Alzheimer’s disease is getting worse.

Research is underway involving Alzheimer’s patient living with agitation and their caregivers.  Dr. Laurence Radin and Andrea Stewart APRN are among the investigators working on a study locally.  Those who wish to learn more about Alzheimer’s agitation and Alzheimer’s research are welcome to call Coastal Connecticut Research in New London at (860) 443-4567.

Alzheimer’s Agitation

Monday, January 22nd, 2018

Are you a stressed out caregiver? Has mom or dad become too much to handle?  Are you a spouse living with someone diagnosed with Alzheimer’s and every day is a struggle?

Agitation in Alzheimer’s disease can be unpredictable and frustrating. Symptoms can include cursing or verbal combativeness, shouting, hitting or kicking, pushing or grabbing, pacing and aimless wandering, general restlessness and more. Does this sound like your loved one?

Neurologist Dr. Laurence Radin and the CCRstudies team  are conducting the TRIAD Research Study.  Individuals with agitation due to Alzheimer’s disease along with their caregivers may be eligible to participate.  The study is evaluating and investigational medication that may help with the symptoms of Alzheimer’s agitation.  Agitation can be defined as the presence of one of more of these behavoirs:  excessive motor activity, verbal aggression, or physical aggression.

Males and females 50 to 90 years of age who have a diagnosis of probable Alzheimer’s disease may be eligible to participate.  The study has approximately 8 clinic visits over the course of 16 weeks. Reimbursement is available for time and travel.

If you know someone living at home, in an assisted living facility or in a nursing home who is living with Alzheimer’s agitation and you would like to learn more about the TRIAD Research Study, call (860) 443-4567 or email marylou@ccrstudies.com.

November is Alzheimer’s Awareness Month

Thursday, November 2nd, 2017

 

CCRstudies is a member of the Alzheimer’s Foundation of America.

November is national Alzheimer’s Awareness Month.

Here at Coastal Connecticut Research, we’ve been heavily involved in the fight against Alzheimer’s.  We have conducted a variety of Alzheimer’s clinical research studies with primary investigator Dr. Laurence Radin, who specializes in neurology.  We have also provided community members with no cost memory screenings

as a public service through the Alzheimer’s Foundation of America’s early detection program.  To date, over 100 no cost screenings have been offered to the public through our Mobile Memory Clinics.

Over 5 million Americans are living with Alzheimer’s disease, a progressive, degenerative condition.  Research will continue to help discover and  develop improved treatments for individuals living with memory loss.

If you or someone you know is living with memory loss, has a family history of memory loss, or would like to learn more about research involving memory loss, call to speak to a member of the CCRstudies team at (860) 443-4567 or email marylou@ccrstudies.com. 

 

No Cost Memory Screenings

Thursday, June 8th, 2017

Coastal Connecticut Research in New London is offering no cost, confidential memory screenings as a service to the community for memory loss or suspected early signs of Alzheimer’s.

If you are concerned about memory loss, have a family history of memory loss, or live with someone experiencing suspected memory loss call Coastal Connecticut Research at (860) 443-4567 to book a screening appointment.  Evaluations take around 30 minutes and results can be forwarded to health care providers with consent.

Since the inception of the Alzheimer’s national memory screening program over 2.5 million people have been screened worldwide.  Locally, Coastal Connecticut Research has conducted over 100 free memory screenings as part of this Alzheimer’s initiative. Memory screenings are a significant first step towards identifying memory problems.   The screenings are conducted by medical staff trained as Qualified Dementia Care Specialists, the highest level of certification awarded by the Alzheimer’s Foundation of America.

Coastal Connecticut Research is located at 342 Montauk Avenue in New London.  Visit www.CCRstudies.com to learn more about the research site.

Understanding Alzheimer’s Research

Monday, May 8th, 2017

Recently, we had the pleasure of attending the first annual Senior Strong Summit in Mystic, Connecticut. The program focused on topics ranging from estate planning to Alzheimer’s disease care giving and research.  The event was organized by the Mystic Geriatrics Institute, an newly formed non-profit with a focus on the changing face of elder care and empowering seniors.

We feel it’s important to participate in such events to educate the public on the important role research plays in the future treatment of disease.  Ideally those who conduct research throughout the world can someday find a cure for this global epidemic of the aging population which currently affects 5 million Americans.  What we shared with those in attendance is the current research at our site takes different approaches to Alzheimer’s.  Some of studies testing investigational medications focus on improving Alzheimer’s symptoms, with a future goal of better treating the disease.   We have tested investigational medications designed to target memory, thinking, reasoning and cognition. We are also in the process of testing an investigational medication for those living with mild dementia designed to promote better sleep.  Observational studies, those studies that do not test a medication, have looked at ways to diagnose Alzheimer’s earlier and more accurately. Some observational studies focus on biomarkers such as blood,  brain wave patterns and Amyloid proteins on the brain.  Just as each and every person is different, each and every research study we conduct is different. Our studies are conducted with highest ethical standards.

As noted to those who attended the Senior Strong Summit, clinical research follows a protocol which is black and white, but Alzheimer’s disease has many shades of gray and creates some complex issues for the person suffering from the disease and those caring for the person living with the disease.   Those who consent to clinical research are participating as volunteers, and their participation can someday help others living with the same condition.

Call us at (860) 443-4567 if you would like to learn more about research or wish for us to participate in your next event.

 

Technology and the Brain

Wednesday, April 12th, 2017

We in the 21st century are living in an advanced age.  At the click of our fingers, we have access to a plethora of information thanks to the world wide web.  Virtually everyone carries a smartphone, a revolution in technology.  So much for looking things up in our “Funk and Wagnalls” encyclopedia!

The advent of technology has also had an impact on modern medicine and research.  Technology that provides “a window on the brain”* has become a part of the clinical trial process for Alzheimer’s research.

To better treat Alzheimer’s, we need to better understand the disease.  Research which looks at markers for having dementia – brain wave patterns, blood, thinking, reasoning, and remembering, can help better diagnose and ultimately monitor Alzheimer’s  in the future.  MRI’s, CT scans and PET scans are also utilized.

A research registry is currently enrolling eligible volunteers ages 50 and above who have cognitive impairment of suspected Alzheimer’s disease.  The research opportunity provides a no cost PET scan (positron emmission tomography),  This “picture of the brain” will help to identify the amyloid plaque (a buildup of sticky protein) in the brain.  These proteins are one of the hallmarks of memory disease.

Those who are interested in learning more about research opportunities for individuals with memory loss are welcome to contact Coastal Connecticut Research at (860) 443-4567.  The memory loss research team includes local neurologist Dr. Laurence Radin, Andrea Stewart APRN, Diane Palmer RN, Jeannine Elliott RN and Jessie Hatfield LPN.

 

 

 

 

 

*The Dana Alliance for Brain Initiatives

Observational Alzheimer’s Study

Tuesday, October 4th, 2016

Volunteers are needed for an exploratory, observational clinical study for memory loss in New London.  The study is looking to see if having markers for dementia, such as brain wave patterns, blood, and cognition will help diagnose and monitor Alzheimer’s Disease more easily and earlier in the future.  Coastal Connecticut Research is seeking individuals in the early stages of memory loss to participate in this clinical research trial.

If you or someone you know living with dementia is under the age of 90, you may be eligible to participate in this clinical research study.  Neurologist Dr. Laurence Radin is the study doctor.  The study team is comprised of highly trained nurses and Qualified Dementia Care Specialists.

Study tests are non-invasive.  All study-related labs, exams and testing are provided at no cost.  No insurance is required. Reimbursement is available for time and travel.  If you have questions or interest in this study, contact a member of the CCRstudies team at (860)443-4567 or email marylou@ccrstudies.com.

Free Memory Screenings at Total Life Expo

Thursday, September 8th, 2016

memory-matters-flyer-not-web-version

Coastal Connecticut Research (CCRstudies) will be providing free memory screenings at the Total Life Expo, presented by the Eastern Connecticut Chamber of Commerce at Mohegan Sun Casino on Saturday, September 17th, 2016.  We’ll be on hand from 10 am to 3pm for those who wish to visit our booth.  The memory screenings are part of the Alzheimer Foundation of America’s National Memory Screening program.

Sarah Ballard, LPN, Qualified Dementia Care Specialist, will be conducting the screenings.  Results are confidential but can be forwarded to health care provided with the consent of the person who has undergone the memory screening.

Admission is free to the event.