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Author Archive

OCD Study Launched

Wednesday, February 17th, 2021

 

Dr. Laurence Radin will be serving as the Principal Investigator of a clinical trial evaluating an adjunct (add-on) study product for OCD.  Andrea Stewart, APRN, Diane Palmer, RN and Kelley Sanok, RN round out the study team.  If you are unsure if you might be an eligible participant for a local research study, you might have some questions.

Frequently asked questions

What is the purpose of a clinical trial?

Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of possible new medications, medical devices, and medical procedures.  Although there are many types of clinical trials, all United States-based clinical trials must conform to strict rules set forth by the U.S. Food and Drug Administration (FDA).  These rules help protect the rights and safety of those who volunteer to take part in clinical trials.

Who is conducting this study?

The study is being conducted on behalf of Biohaven Pharmaceuticals by multiple sites (research clinics or hospitals) across the United States with trained, qualified, medical specialists.

Will I have to pay anything to participate?

No. If you qualify and are chosen to participate, you will receive all study-related care, including investigational study drug, at no cost to you.

I’m not sure if I have OCD, can I still participate?

If you think you have OCD, a clinician will evaluate you if you are eligible.

How many people will participate in this study?

About 2,000 people will participate in this study.


      

Valentine’s or Galentine’s?

Wednesday, February 10th, 2021

Are you celebrating Valentine’s Day this month or Galentine’s Day?  And, given the fact we’re still social distancing, how will you celebrate either?

February conjures up a few images in these parts.  Snow….we’ve had a lot of it lately, and of course, Cupid and his arrow.  Whether you are celebrating Valentine’s Day with a significant other, or maybe just bestowing someone dear to you with chocolate heart, we wish you happiness. And, for those of you who aren’t interested in the romance but the fun, well, perhaps you are celebrating a virtual event with friends over ZOOM responsibly toasting to Galentine’s.

We’d like to think romance is still alive and well despite the fact the rituals of dating might look different currently.  For those of you who are in a relationship, if things are getting “hot and heavy” so to speak, please keep in mind we’re currently conducting a birth control study evaluating an investigational oral contraceptive for women.  We’d love to tell you more about this study!  Feel free to reach out at (860)443-4567 or email marylou@ccrstudies.com.  You can also sign up online at http://www.ccrstudies.com/current-trials/#!/study/13.

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!

2021- Looking Ahead

Monday, December 21st, 2020

2021 – the promise of a new year!  2020 was a year like no other.  Some people cannot wait to say goodbye to the year in which our global community dealt with the impact of Covid-19.  Many lives were lost, our way of life changed drastically, and turmoil abounded.  Some found opportunities to grow and thrive. Others faced daily challenges.  So many are breathing a collective sigh of relief as we look ahead to some global healing as the vaccination process begins.

Here at Coastal Connecticut Research we are looking ahead to 2021 and excited to roll out some new studies and will continue enrolling for some studies which we began recruiting for prior to the pandemic.  Our early  2021 studies include clinical research trials evaluating study products for birth control, migraine headaches, memory loss and Parkinson’s disease, Obsessive Compulsive Disorder, and more to be listed.  As always, our research volunteers play a key role in the success of these research studies.

We’re looking forward to keep you posted on all that is happening here in the coming year!  Call (860)443-4567 to learn more, e-mail marylou@ccrstudies.com or sign up here on our website.

December 2020

Tuesday, December 8th, 2020

 

It’s the end of 2020 – what a year it has been!  We are so fortunate to have such dedicated study volunteers. During a global pandemic, in times of absolute uncertainty for many, our dedicated research volunteers continued their participation in clinical research studies.  As a matter of fact, clinical trials have been all the buzz lately as the entire world seemed to wait with baited breath as vaccines were trialed and approved for use.

As we look ahead to 2021 we continue to acknowledge to most important aspect to our enrolling studies is the connection we have with you – our volunteers!  Thank you for taking the time to give of yourself and ultimately help to advance medicine.  We have some exciting trials on the horizon and will continue to enroll for our current studies.

Wishing you the happiest of holidays season, peace and good health!

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.

 

Are Migraines Affecting Your Work?

Tuesday, October 20th, 2020

Do migraine headaches affect your work? Do you work at least 20 hours per week?    A migraine research study is being conducted locally at Coastal Connecticut Research in New London, evaluating an investigational migraine medication versus placebo and its effect on workplace productivity.

If you’re an adult living with migraines and you work at least 20 hours per week you may be eligible. There’s no cost for the investigational medicine or placebo and no cost for any study-required procedures. You may also be reimbursed for your time and travel. Neurologist Dr. Laurence Radin and Andrea Stewart, APRN are members of the local research team.

Call 860-443-4567, sign up online at ccrstudies.com or text the keyword CCR to 74121. Call today to learn more about the workplace productivity migraine research study.  860-443-4567.  443-4567.

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.