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Archive for the ‘ News Feed ’ Category

What’s Happening at CCRstudies

Wednesday, January 20th, 2021

It’s a new dawn, it’s a new day as Nina Simone so beautifully sang. 2021 has held hope for quite a few people.
At Coastal Connecticut Research in New London, we are continuing to forge ahead with being on the forefront of a worldwide effort to improve the qualify of life for people living with a variety of conditions.  Clinical research is the pathway to developing new products and treatments for individuals throughout the world.

Recently, a study patient noted how much she has enjoyed participating in research. She said her friends often ask her “why do you do those studies?” and her reply was “why wouldn’t I?”  She noted the interest the medical team takes in her health, the time they take with her to answer her questions on a variety of topics, and the fact she never feels rushed when her study visits are conducted. Women and men from throughout the region have taken the time to help others by participating in clinical research trials.  We thank them!

This year, we are looking forward to launching a variety of new studies at our site.  We encourage people who have questions on research to contact us directly.  You can reach out by phone at (860)443-4567 to talk to a member of the study team, email marylou@ccrstudies.com or even sign up for a study online http://www.ccrstudies.com/current-trials/#!/ and we will contact you.  Text the keyword CCR to 74121 and we can also get the conversation started.

Your role in research begins by taking the first step.  We’re happy to share with you what you might be able to expect!

OCD – Obsessive Compulsive Disorder

Thursday, November 19th, 2020

Out of control thoughts, images, and obsessive behaviors and the inability to control these thoughts, images and behaviors. This is a simple explanation of an extremely complicated mental illness – Obsessive Compulsive Disorder, also known as OCD.  This goes far beyond someone’s idea of obsessive cleaning or obsessive handwashing. There are considerable layers to this condition and it can manifest itself in a variety of ways.

Coastal Connecticut Research will be conducting a clinical research trial evaluating a study product for individuals living with OCD.  This condition can affect people of all ages and from all walks of life.   Further details on the trial will be made available as the enrollment period nears.  Those who may wish to learn more about research in this area are welcome to call and speak to a member of the CCRstudies team at (860)443-4567 or email marylou@ccrstudies.com.

Migraine Research

Monday, November 9th, 2020

 

You’re at work – or, at least you’re trying to work thanks to your throbbing head and migraine.  You’re working from home, the pain is so intense your productivity is shot. Does this happen to you?  Migraines can vary in intensity but one thing is for sure, you cannot necessarily proceed as normal  when you get a migraine.  Those living with migraines may experience nausea, sensitivity to lights and sounds, and for many, debilitating pain.

Coastal Connecticut Research is currently enrolled in migraine research trial evaluating the study product and it’s effect on productivity in the workplace.  Have your migraines affected your ability to get the job done?

There is no cost to participate in this clinical research study, no cost for the study product, and all labs, exams and testing are provided at no cost. In addition, reimbursement is available for eligible participants who enroll in the research trial.  Neurologist Dr. Laurence Radin is the principal investigator of the study and Andrea Stewart, APRN is a sub-investigator on the study.  To learn more, call (860)443-4567 or text the keyword CCR to 74121. You can also sign up online at CCRstudies.com to receive further information.

 

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. 

Birth Control Study

Wednesday, June 17th, 2020

 

Did you know at one time in our history animal dung was used as barrier contraception?  Did you also know in our history here in the United States up until the 1960’s it was illegal for a woman to use contraception?  We’ve come a long way.

While a variety of contraceptive products are available for a woman’s reproductive health, researchers continue to explore options for those in their reproductive years who do not wish to conceive, or who are looking to help control the sometimes painful and uncomfortable symptoms of menses.

Coastal Connecticut Research is currently conducting a clinical trial evaluating an investigational birth control product. The study is enrolling eligible women ages 18-45 years old.  Dr. Robert M. Spitz is the study gynecologist.  There is no cost to participate in the study and no cost for the investigational birth control pill which will be used by participants for one year.  Reimbursement is available to time and travel. Those wishing to learn more can text the keyword CCR to 74121 or call (860)443-4567. Email marylou@ccrstudies.com  if you have further questions. The CCRstudies team is always happy to speak with you to educate you regarding our clinical research trials and the important role of the study volunteer.

Keeping Our Patients Safe and Healthy

Thursday, May 7th, 2020

Thank you for your continued participation in research during these unprecedented times.

In order to continue to operate safely, we request you inform our site if you have been in contact recently with someone who has tested positive for COVID-19. This could be a family member you live with, a colleague at work, or someone you may care for.

As you are aware our site has a variety of measures and protocols in place in order to comply with social distancing initiatives and to keep our patients and staff safe and healthy.

We appreciate your support in this endeavor and thank you for being a dedicated research volunteer.

You are welcome to call us at (860)443-4567.

Thank you again for your cooperation and participation.

Dr. Robert M. Spitz

Medical Director

Coastal Connecticut Research

 

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.

Diabetic Foot Pain

Tuesday, March 20th, 2018

You were diagnosed with Type 2 diabetes several years ago and with that, you were aware that you would have to make some lifestyle and dietary changes.  What you didn’t expect when you received that initial diagnosis was someday your feet would feel like they were on fire.  What’s happening?

Diabetic Peripheral Neuropathy, known as DPN for short, is a complication of Type 2 diabetes that occurs in over half of those living with the disease. Due to nerve damage as the result of diabetes,  people living with DPN experience pain in their legs and/or feet, tingling, numbness, burning and general discomfort. Some people feel like they are walking on pins and needles.  Others cannot get a decent night’s sleep and wake up at the slightest provocation including something as simple as a blanket rubbing against their feet.

Coastal Connecticut Research is currently involved in a diabetic nerve pain study testing an investigational medication.  People who have Type 2 diabetes and are experiencing nerve pain in their feet and/or legs may be eligible to participate in this clinical research study.  Dr. Edward McDermott is the primary investigator of the study.  Enrolled participants receive the study product and all study-related procedures at no cost.

Anyone who wishes to learn more about clinical research is welcome to call and speak to a member of the CCRstudies team at (860) 443-4567.

 

 

 

Diabetic Foot Pain

Thursday, February 22nd, 2018

Tingling, numbness, burning.  Your feet are on fire!  Why?  Because you’ve developed diabetic peripheral neuropathy.  Diabetic peripheral neuropathy, also known as DPN,  develops in over half of all individuals living with Type 2 diabetes.  Nerve pain can make life go from comfortable to miserable!

Dr. Edward McDermott is the primary investigator in a research study being conducted in New London for foot and leg pain associated with diabetes.  Volunteers in the study will evaluate an investigational product that may help with the leg and foot discomfort.  No insurance or cost is needed to participate.  Those with throbbing feet and Type 2 diabetes may wish to call and learn more.  (860) 443-4567.