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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. 

A Hot Flash Story

Wednesday, September 16th, 2020

Have hot flashes impacted your multi-tasking?

Once upon a time there was a lady who had been through menopause suffering with hot flashes.  She had to throw the covers off her at night due to such profuse sweating and during the day, constantly fanned herself to stay cool. One day, the woman heard a radio commercial about a clinical research study enrolling in New London evaluating a product for women with hot flashes.  She called the site, answered some questions over the phone, and learned she qualified for the study. But alas, the lady was hesitant to participate. She was a bit uneasy about trying something that was not yet available for prescription.  She said she had to think about it, and so she did.  The lady told one of the members of the CCRstudies team at the research site she was a bit uneasy. After learning more about the study product and the design of the study, she felt better informed. She even learned one of the products she took everyday had been evaluated in the past at the very same sight!  The lady had never thought twice about taking this product and realized people like her must have participated in a clinical trial in order for the medication to gain FDA approval. This changed her way of thinking – she decided she too wanted to help others.  It was no longer just about her hot flashes, but rather, she gained a greater understanding of the importance of being a research volunteer.  The lady had already found her prince years ago, she wasn’t very concerned about that sort of happy ending. What made more of a difference to her was the fact she could ultimately impact someone else’s life by participating in a clinical trial.

Why Volunteer?

Wednesday, September 2nd, 2020

You’re a busy person. We get it. There is an old saying which goes something like this, “if you want to get something done, just ask a busy person.”  We are truly appreciative of all those individuals who come forward to participate in research. It is a form of service to others who someday may benefit from the study product you are evaluating.  Volunteers in our research studies come from all walks of life – nurses, engineers, stay-at-home parents, retail workers, students, teachers, retirees, scientists, home-health aides, municipal employees, the list goes on.  What these individuals have in common is a desire to help others by participating in research.

Today as we as a nation deal with a “new normal” due to the Covid-19 pandemic, we want to assure those participating in research and those interested in research, that we are operating in accordance with CDC guidelines and precautions in regards to keeping you and our team safe.  The health and safety of all those in our studies was always of paramount concern and with heightened protocols, it is still our greatest focus.  So, thank you for putting your trust in us.  We will work extremely hard to continue to do our very best.

If you are interested in learning more about the clinical research process and how you might get involved, reach out!  We offer no-contact prescreening over the telephone for our currently enrolling studies and are happy to speak with you candidly regarding the research process.  Call (860)443-4567 or text the keyword CCR to 74121. You can also sign up for a study online here on our website  – just click and apply!  E-mail your questions to marylou@ccrstudies.com.  We look forward to hearing from you and sharing information!

Dog Days of Summer – and Then Some!

Monday, August 10th, 2020

Did you think your back to school shopping for your student (whether this be preschool or college) would include face masks?  We are five months into an altered way of life here in Eastern Connecticut.  Thankfully, our state has been working hard to combat the pandemic our fellow global citizens have been faced with.

Please know we here at Coastal Connecticut Research put patient safety first.  We have worked extremely hard to provide an environment suitable for the utmost quality study-related care. We also greatly appreciate our valued study volunteers who are the heart and soul of the clinical research trials we conduct.

We understand some people are extremely uneasy about venturing out during this times. If you have any concerns or questions regarding study participation, feel free to call us at (860)443-4567.  We’d love to get the conversation started with you and address any questions you may have.

Our region has so much to offer, especially in the summer.  We hope during these socially distant times you are still able to connect with what is important to you – whether this be a day at the beach or on the water, a walk in one of our lovely parks, or a conversation with a good friend.  As we are told to keep six feet away, sometimes our connections have to take on a new look.

Wishing you good health and happiness as the dog days of summer roll along!

Summer Heat and Hot Flashes

Tuesday, July 21st, 2020

This summer looks a little different than past years.  Did you ever think you would be walking on the beach with a mask on?  Or, did you ever think you wouldn’t be able to actually get on the beach due to limited capacity?  We are completely on board with social distancing and flattening the curve! We get it!   One thing about summer remains the same – heat and humidity!  For women suffering with hot flashes, there seems to be no relief.

Coastal Connecticut Research is currently involved with hot flash research.  Postmenopausal women who have been living with hot flashes and night sweats have been coming forward to participate in a study evaluating an investigational medication for the condition.  The study is continuing to enroll qualified local women who may be experiencing these symptoms and who have an interest in participating in research.  We thank all volunteers! Some women have referred to hot flashes as “their own personal summer.”  We understand your personal summer can be a big bummer, even more so when it’s 95 and humid!

People who wish to learn more about research are encouraged to contact us.  We are happy to share information with you.  E-mail marylou@ccrstudies.com, text the keyword CCR to 74121 and we’ll call you back, or simply give us a ring at (860)443-4567.  We look forward to connecting!

Birth Control Research

Thursday, July 9th, 2020

A recent decision by the United States Supreme Court is expected to make obtaining access to affordable birth control by prescription considerably more difficult for some women whose employers do not wish to cover those services.  Under the Affordable Care Act, women were supposed to be granted access to no cost contraception.  Unfortunately, many women who wish to engage in responsible family planning are not always able to afford a monthly prescription to a birth control pill or other contraceptive product.

Clinical research is underway in New London evaluating an investigational, oral birth control product.  Not everyone is aware there is no cost to participate in a clinical research trial and no cost for the study product.  All labs, exams and testing are available at no cost.  Women will also receive the birth control study product for one year at no cost.  Reimbursement may also be available for time and travel.

Some choose to participate in research because they like the feeling of helping others.  Some choose to participate in research because their health care options are limited, they are uninsured or under-insured, and they appreciate the no-cost study related healthcare.  Decisions to participate in research are personal, but the impact of volunteering creates a ripple effect in regards to helping to advance medicine.

If you wish to learn more about clinical healthcare research studies in New London, call to speak to a member of the CCRstudies team at (860)443-4567. You can also email marylou@ccrstudies.com or text the keyword CCR to 74121.

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.

Birth Control Product Gains FDA Approval

Monday, June 1st, 2020

Exciting news!  A birth control product for use “in-the-moment,” evaluated by study participants at Coastal Connecticut Research, has gained FDA approval.  Thank you to our volunteers for participating in this women’s healthcare research study.

U.S. FDA Approves Evofem Biosciences

Phexxi TM (lactic acid, citric acid and potassium bitartrate),
the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy
A New Class of Female-Controlled Birth Control for Use In-The-Moment

SAN DIEGO, May 22, 2020 — Evofem Biosciences, Inc. (NASDAQ: EVFM) today announced that the U.S.
Food and Drug Administration (FDA) has approved Phexxi  TM (lactic acid, citric acid and potassium
bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an
on-demand method of contraception.

Phexxi is the first non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain
vaginal pH within the normal range of 3.5 to 4.5 an acidic environment that is inhospitable to sperm.
There have been a limited number of advances in birth control over the last two decades.

As the first vaginal pH regulator with a unique mechanism of action, the Company is working to have
Phexxi covered under the Affordable Care Act (ACA). The ACA mandates that private health plans provide
coverage with no out-of-pocket costs for one treatment per class in each of the classes identified by the
FDA for women in its Birth Control Guide.

Evofem is committed to ensuring access to Phexxi for all women seeking non-hormonal contraception,
including for women who are not covered by government or private health plans, and will provide a
financial assistance program to enable access for eligible women.