Conducting clinical research studies with
SKILL, KNOWLEDGE and SAFETY.
Call to participate
860.443.4567

Archive for the ‘ Volunteers ’ Category

Hot Flash Study in New London

Thursday, October 14th, 2021

It’s 3am. You can’t sleep. Why?  Because you’re hot. Really hot. Covers get thrown off, window’s open (did we mention it’s 50 degree outside and your heat is off?  Well, at least the thermostat is off, you’re on fire.)  Hot flashes. Night sweats.  You have them and they make you feel miserable!

Do you ever wonder why Eve ate that apple?  You would think all the symptoms associated with womanhood and “Eve’s curse” would end once your period did, right?  Well, then menopause comes along to make sure you feel a bit more jumbled.  Menopause, once known as the “change of life” for many women, can signify some major changes with your body. Thanks to hormonal shifts, many women find their internal thermostat set on summertime mode – hot and humid. Lack of sleep thanks to night sweats, embarrassment and discomfort thanks to hot flashes can certainly lead to anxiety during the pivotal time in one’s life.

If you are a woman who has been through menopause (the loss of your monthly menstrual period), and you’re interested in participating in women’s healthcare research, a study evaluating a non-hormonal investigational medication for hot flashes is something you may be interested in learning more about.  Email marylou@ccrstudies.com or call (860)443-4567.  We’re happy to inform you of current research in women’s healthcare.

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!

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

 

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!

Doing Our Part!

Tuesday, April 21st, 2020

It’s been quite a month here in Southeastern Connecticut as we work together to flatten the curve against COVID-19.  Please allow us to thank our many study volunteers to continue to participate in research.  We would also like to thank the doctors, nurses, pharmacists, first responders, grocery store workers, and all those staffing essential businesses who are on the front lines of the Coronavirus pandemic. We also offer our deepest condolences to those families who have lost a loved one as a result of COVID-19.

Research is underway throughout the world trying to create an effective vaccine for the disease. Now more than ever, we shine a light on how important research is to improving our world.

It seems that many of us are living day to day, doing our best to comply with social distancing and keep others safe and healthy.  Spring in New England is typically a time we witness blossoming beauty all around us.  Here is hoping our world can heal and we can all do our part to stay safe, healthy and keep others safe and healthy.

 

How Are You Doing?

Tuesday, April 7th, 2020

How are you doing?  We sincerely hope you and your loved ones are in good health.  A few months ago who knew the term “social distancing” would become such a part of our everyday lives?  We appreciate all of our study volunteers who have continued to participate in research (with the proper safety measure and protocols in place.)  We also are proud to work in the important field of research. Many Americans who were once unfamiliar with the term “clinical trial” are beginning to hear more about how important it is to find new ways of treating disease, illness and chronic conditions.

While life as we once knew it may be temporarily on hold, there are many things you can do to continue to enjoy your quality of life.  Journal.  Keep a gratitude list. Go out for a walk each day (keeping proper social distance of course!)  Gaze up at a clear blue sky. Play with your dog.  Hug your kids.  Place a zoom call with some old friends.  Play scrabble.  Sit down for a meal with your family.  Smile. Breathe deeply.  Meditate. You get the picture.

We are still screening patients for our hot flash study and are pre-screening patients over the telephone for studies including migraines and work productivity, Parkinson’s disease, birth control and Alzheimer’s disease.  If you wish to learn more, contact us, we’re here – (860)443-4567.

Stay well!

Who Participates in Research?

Monday, September 17th, 2018

Have you ever been curious who participates in clinical research?  People just like you, that’s who!

Coastal Connecticut Research in New London has welcomed volunteers from the community for many years.  Doctors, teachers, lawyers, grandparents, young mothers, young fathers, middle-aged professionals, empty nesters, and people from all walks of life participate in clinical research. What these individuals have in common is their desire to help others through giving of their time, one of their most precious resources.

Some people who participate in research have said they have “tried everything” for a particular condition and therefore want to evaluate a study product that might someday be made available for prescription.

We are truly grateful for each and every volunteer who walks through our door to be a part of clinical research studies.  If you are interested in learning more, call to speak to a member of the CCRstudies team at (860) 443-4567.  There is no cost to participate in research, no insurance is needed, and there is no cost for study-related care.

Does Frequent Urination Impact Your Summer?

Monday, July 9th, 2018

Summer’s here.  So many things to do – beaching, boating, hanging out at picnics.  The only problem is, you pee all the time and avoid these activities.  If you can’t be near a bathroom, you can’t go.

Many women live with the symptoms of Overactive Bladder also known as OAB but are too embarrassed to discuss this issue.  The frequent and urgent need to urinate, having some leakage or wetting accidents, and getting up in the night to pee are some of the symptoms of OAB.  Sound like you?

Coastal Connecticut Research is conducting a research study evaluating an investigational medication for women who live with Overactive Bladder.  Study gynecologist is Dr. Robert Spitz.  If you are a woman who is living with the symptoms of OAB and you are interested in learning more about research, call (860) 443-4567 to speak with a member of the CCRstudies team.

Thank You Volunteers!

Wednesday, June 6th, 2018

We here at Coastal Connecticut Research in New London are constantly amazed at what great volunteers we have. People who come to our site to participate in research and ultimately help others.  At the end of each study we like to ask our volunteers to evaluate their experience.  Here’s what they’re saying:

“It was a great first experience for a clinical research trial….I hope to participate in future studies for the sole benefit of helping future patients.”  K.

“The staff is a kind and caring professional group. I enjoy my time spent with them.  They make me feel special too.”  J.

To our volunteers – THANK YOU! To those who are considering participating in research – give us a call to learn more!  (860) 443-4567.