Clinical Trials

Neurological Associates of Long Island is conducting clinical trials in neurological diseases such as Alzheimer’s Disease, Multiple Sclerosis, and Stroke. Clinical Research is conducted to ensure the safety and effectiveness of innovative disease treatments. Study participants benefit by having a more active role in disease management, access to new treatments, and contribution to the future of healthcare.

ALZHEIMER’S DISEASE

VTV THERAPEUTICS STEADFAST STUDY

What is the STEADFAST Study?

The STEADFAST Study is a clinical trial, or research study, that will evaluate a new investigational medication, azeliragon (TTP488), as an addition to many of the commonly prescribed medications for patients with mild-stage Alzheimer’s disease. Azeliragon works by blocking a receptor in the brain that binds to substances such as amyloid beta, a protein thought to contribute to the symptoms of Alzheimer’s disease.

There will be two groups of people in the study:

  • One group will receive azeliragon (5 mg daily taken orally) in addition to their regular medication(s).
  • One group will receive a placebo (a substance with no active ingredients) in addition to their regular medication(s).

Why should I consider participating in the STEADFAST Study?

  • By participating in this study, you can learn more about the treatment of Alzheimer’s disease.
  • You may receive the study medication, azeliragon, which may be effective at slowing the progression of Alzheimer’s disease
  • Participating in studies helps advance research, which may help the future treatment of this currently incurable disease.

What will I need to do for the STEADFAST Study?

  • The study will last approximately 23 months and involves about 9 visits to the doctor’s office, with most visits occurring every 3 months.
  • You must attend all study visits with your caregiver.
  • You will need to take your study medication every day, as instructed.
  • You must continue to take your regular Alzheimer’s disease medication as you normally do.
  • You will need to tell the study doctor of any changes to your health or medications while in the study.

Study Investigators: Dr. David Podwall, Dr. Teresa DeAngelis, Dr. Michael Han

ClinicalTrials.gov Identifier: NCT02080364

For more information: https://clinicaltrials.gov/ct2/show/NCT02080364?term=steadfast+study&rank=4

 

MERCK INSOMNIA IN ALZHEIMER’S PATIENTS STUDY

What is the purpose of this clinical research study?

This study is evaluating the effectiveness, safety, and tolerability of an investigational study medication for patients with insomnia and Alzheimer’s disease.

What medication is being studied?

This research study is evaluating whether the study medication suvorexant is safe and effective, compared with placebo, in improving insomnia in patients with insomnia and Alzheimer’s disease. The study medication is approved for certain uses in the U.S. and Japan but is considered investigational for other uses and in other countries.

How long will study participation last?

Each patient will participate in the study for approximately nine weeks. After a screening period of approximately three weeks, the study doctor will determine your eligibility to participate in the study. Following the screening period, each patient will be randomly assigned to receive either an inactive placebo or active investigational medication for approximately four weeks. In addition to receiving study medication, each patient will be asked to complete three overnight visits for sleep studies to assess their insomnia. After the end of the four-week treatment period, each patient will receive a follow-up phone call approximately 14 days after treatment.

Who is eligible for this clinical research study?

This study will enroll approximately 260 adults from various countries who meet the following criteria:

  • Are between the ages of 50 and 90 (inclusive)
  • Have a DSM-5 diagnosis of insomnia and a diagnosis of mild to moderate Alzheimer’s disease
  • Have a reliable and competent trial partner who is willing to comply with the administration and completion of study procedures and assessments
  • Does not reside in a nursing home or similar institutional facility

Whom can I speak with to learn more about this clinical research study?

For more information about the study and the possible risks and benefits of participation, please contact the study doctor.

 

Study Investigators: Dr. David Podwall, Dr. Michael Han, Dr. Raminder Parihar

ClinicalTrials.gov Identifier: NCT02750306

For more information: https://clinicaltrials.gov/ct2/show/NCT02750306?term=mk4305&rank=4

 

MERCK SHARP & DOHME CORP. EPOCH STUDY

Closed for Enrollment

A Randomized, Placebo Controlled, Parallel-Group, Double Blind Efficacy and Safety Trial of MK-8931 With a Long Term Double-Blind Extension in Subjects With Mild to Moderate Alzheimer’s Disease (Protocol No. MK-8931-017-10) (Also Known as SCH 900931, P07738)

Purpose: The clinical trial will assess the efficacy and safety of verubecestat (MK-8931) compared to placebo during 78 week for Alzheimer’s Disease (AD). Participants may choose to participate in a long term double-blind extension phase for up an additional 260 weeks. Your participation in this study is completely voluntary.

Study Investigators: Dr. Teresa DeAngelis, Dr. David Podwall and Dr. Michael Han

ClinicalTrials.gov Identifier: NCT01739348

For more information: https://clinicaltrials.gov/ct2/show/NCT01739348?term=MK-8931-017&rank=1

 

MULTIPLE SCLEROSIS

PLEGRIDY® (PEGINTERFERON Β-1A) REAL WORLD EFFECTIVENESS AND SAFETY OBSERVATIONAL PROGRAM

Project/Study Title: PLEGRIDY (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program

Why is this study being done?

The purpose of this observational study is to identify the long-term safety and effectiveness of PLEGRIDY, over approximately a five-year time period. Information on quality of life, side effects, relapses, and disability progression in patients taking PLEGRIDY will be collected. You do not need to come to the clinic for any extra visits as you will see your doctor as part of your regular care. Your participation in the study is voluntary.

Study Investigators: Dr. Teresa DeAngelis and Dr. Richard Blanck

ClinicalTrials.gov Identifier: NCT02230969

Link for more information: https://clinicaltrials.gov/ct2/show/NCT02230969?term=NCT02230969&rank=1

NOVARTIS PASSAGE STUDY

Study Investigators: Dr. Teresa DeAngelis and Dr. Richard Blanck

ClinicalTrials.gov Identifier: NCT01442194

Link for more information:  https://clinicaltrials.gov/ct2/show/NCT01442194?term=novartis+passage&rank=1

 

 

TEVA PHARMACEUTICALS CONFIDENCE STUDY

CLOSED FOR ENROLLMENT

CONFIDENCE Research Study: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily

Why is this study being done?

The purpose of this study is to compare patient medication satisfaction between the Copaxone 40 mg/mL three time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) groups.

After 6 months of either treatment assignment, all subjects will enter the 6 month extension phase where all subjects will receive Copaxone 40 mg/mL three time a week (TIW). Study participation is 12 months in total and completely voluntary.

We are looking for adults who are at least 18 years of age or older with Relapsing remitting Multiple Sclerosis to participate in this 12 month research study.

Qualified participants will receive:

  • Study-related medical evaluations
  • Study-related investigational medications
  • Compensated for time and travel may be provided

Principal Investigator: Teresa DeAngelis, MD

Study Investigators: Dr. Teresa DeAngelis and Dr. Richard Blanck

Reference:

ClinicalTrials.gov Identifier: NCT02499900

Link for more information: https://clinicaltrials.gov/ct2/show/NCT02499900?term=copaxone&rank=19

FOR MORE INFORMATION ON ELIGIBILITY AND THE POSSIBLE RISKS AND BENEFITS OF PARTICIPATION, PLEASE CONTACT THE STUDY COORDINATOR:

STELLA GURGOVA

516-466-4700 EXT 140

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