Current Research

 

ALZHEIMER’S DISEASE RESEARCH


CREAD: Study of Crenezumab in Patient’s with Prodromal to Mild Alzheimer’s disease

This Phase 3 trial is looking for people ages 50-85 in the early stages of memory issues to take part in a 2 year study of an investigational drug. In this study, participants will get either Crenezumab or placebo in addition to any background therapy you may or
may not be receiving. 

Interested patients will be consented to begin screening procedures such as memory assessments, physical, labs, MRI and PET scan at no cost. If qualified, participants will visit our site once per month for an infusion of the study drug. It is hoped that, if it works, Crenezumab may slow down how fast the disease progresses. 

For more information, please contact Amanda Jamison at 716-819-4117

Alzheimer’s Disease Neuroimaging Initiative 3 (ADNI3)

 

The Alzheimer’s Disease Neuroimaging Initiative (also known as ADNI) is a historic study of brain aging looking to help change the future for this disease.

If you are 55 to 90 years of age, you may be able to help if you:

·         Are in good general health

·         Have a diagnosis of early AD, Mild Cognitive Impairment (MCI) or are cognitively normal

·         Are willing and able to undergo in-clinic assessments, memory testing and other test procedures

·         Have a study partner who can accompany you to all clinic visits

·         Are fluent in English or Spanish

 

This is a free study. No experimental medication will be involved.

To learn more, please visit http://www.adni3.org/  or contact Caroline Kumm at 716-558-3492 or ckumm@dentinstitute.com

 

Agitation in Alzheimer’s Disease

 

TRIAD™: Study of AVP-786 for the Treatment of Agitation in Patients with Dementia of the Alzheimer’s type.

The TRIAD™ Research Study is currently evaluating an investigational medication to see if it may reduce symptoms of agitation due to Alzheimer’s disease.

 

To be eligible for this study, patients must:

•         Have moderate to severe agitation* due to Alzheimer’s disease

•          Be between 50 and 90 years of age

•         Have a caregiver able to attend all study visits

 

This study will include:

•         Study-related medical exams and assessments at no cost

•         Potential compensation for time and travel

 

* Agitation can be defined as the presence of one or more of the following behaviors: excessive motor activity (eg, pacing or wandering), verbal aggression (eg, screaming or cursing), or physical aggression (eg, hitting or kicking).

 

To learn more about this study, please contact Caroline Kumm at 716-558-3492 or ckumm@dentinstitute.com

 


RECOGNITION:  Study of Piromelatine in Patients with Mild Dementia Due to Alzheimer’s Disease

The purpose of this Phase 2 research study is to determine an effective dose of a once a day tablet, piromelatine, in patients with Mild AD between the ages of 60-85.

The study will take place over 7 months and include visits to our site and weekly telephone calls. The potential sleep enhancing capacities of piromelatine may also be important to the study. Recent clinical and biochemical evidence has identified an interesting link between sleep, cognitive dysfunction and Alzheimer’s disease. Patients will be randomly assigned by chance to receive either piromelatine (5mg, 20mg, or 50mg) or placebo.

For more information, please contact Amanda Jamison at 716-819-4117.


 

BRAIN TUMOR/ONCOLOGY RESEARCH

For information regarding brain tumor and oncology research contact Rebecca Hogan, Clinical Research Coordinator, at 716-558-5670

EPILEPSY RESEARCH 

Epilepsy with Partial Seizures

A0081096 – Prospective Randomized 12-Week Controlled Study of Visual Field Change in Subjects with Partial Seizures Receiving Pregabalin or Placebo.

If you have been diagnosed with Epilepsy with partial seizures and are currently taking up to three medications for its control, you may be eligible to participate in a research study evaluating an investigational medication to be added to your current therapy.

All study related visits and tests are provided at no cost for the study duration. In addition, epilepsy medications prescribed by the study doctor will be provided to you at no cost for six months after you complete the study. Reimbursement for travel and inconvenience is also provided.

For more information, please contact Jamie So at (716) 558-3488.

HEADACHE/MIGRAINE RESEARCH

Chronic Migraine

If you suffer from 15-26 headache days a month and are between 18 and 65 years of age you may qualify for exciting new research using CGRP therapy. If you are interested in participating please call 716-558-5670.

Episodic Migraine

To qualify for these trials you must be 18-65 years of age and suffer from 2-14 migraine headache days per month. The trials include both prophylactic and abortive medications. If you are interested in participating please call 716-558-5670.

Cluster Headache

To qualify for these trials you must be between 18-70 years of age and have a 1 year history of cluster headache diagnosis. If you are interested in participating please call 716-558-5670.   

MAJOR DEPRESSIVE DISORDER RESEARCH

LVM-MD-11: Safety and Efficacy of Levomilnacipran ER (Fetzima) in Adolescent Patients With Major Depressive Disorder

The purpose of this research study is to evaluate the drug levomilnacipran extended-release for how well the drug works, the side effects, and how well tolerated compared to placebo in adolescents (12-17 years of age) with depression. 

Participation will last about 10 weeks and will include 9 visits to the study center. Patient’s will be randomly assigned study drug to compare Levomilnacipran ER 40 mg/day, Levomilnacipran ER 80 mg/day, Fluoxetine (Prozac) 20 mg/day, and placebo. All tablets will look the same.

For more information, please contact Caroline Kumm at 716-558-3492.

MULTIPLE SCLEROSIS RESEARCH

PASSAGE: Safety Study in Patients with Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies

For this study, relapsing-remitting multiple sclerosis (RRMS) participants must be starting either Gilenya at time of study entry, starting another approved DMT, or have started a DMT within the past 6 months: Betaseron, Extavia, Avonex, Rebif, Copaxone, Aubagio and Tecfidera.

For more information, please contact Caroline Kumm at 716-558-3492.

FLUENT: The FLUENT MS Study is for patients who have relapsing MS and who will begin fingolimod therapy OR have been taking fingolimod therapy for at least 2 years.

What is the purpose of the FLUENT MS Study?

  • The study will help determine how a medicine called fingolimod affects the immune system
  • The effect will be studied by measuring substances in the blood called biomarkers

How long is the FLUENT MS Study?

  • Participation lasts about a year and requires 4 blood samples to be taken at baseline (your first study visit after you qualify) and approximately 3, 6, and 12 months

Why should I participate?

  • Your participation may help other people like you in the future who have MS

Can I take part in the FLUENT MS Study? You may qualify if you:

  • Are at least 18 years old
  • Have been told by your doctor that you have relapsing MS
  • Will be prescribed fingolimod OR have been on fingolimod for at least 2 years

You may NOT take part if you:

  •  Have had certain types of heart disease, such as heart attack or heart failure, in the last 6 months
  •  Have had a stroke or a transient ischemic attack, also known as “TIA”
  •  Are taking certain antiarrhythmic drugs, sometimes known as heart rhythm-control drugs

*additional eligibility requirements must also be met

For more information, please contact Caroline Kumm at 716-558-3492 or ckumm@dentinstitute.com

PARKINSON’S DISEASE RESEARCH

Study to investigate the efficacy safety and tolerability of PF-06649751 in subjects with motor fluctuations due to Parkinson’s disease. 

Parkinson’s disease affects millions of people worldwide and there is currently no cure. If you have been diagnosed with Parkinson’s disease, you might be eligible to participate in our clinical research study. The purpose of this research study is to evaluate the safety and the effects of different doses of the investigational medication or placebo taken with Levodopa (L-Dopa) as a treatment for Parkinson’s disease.

Participant Eligibility:
• You are a male or female between the ages of 45 to 85 with Parkinson’s disease.
• You are on a daily dose of at least 400mg of L-Dopa
• You experience motor fluctuations and “wearing off”symptoms

Qualified volunteers will receive study-related medical evaluations at no cost. Compensation for time and reasonable reimbursement for travel related expenses are available.

For more information, please contact Dr. Traci Aladeen at 716-558-9918.

RESTLESS LEG SYNDROME RESEARCH

XP109: Efficacy and Safety Evaluation of HORIZANT in Adolescents Aged 13 to 17 Years Old with Moderate-to-Severe Primary Restless Legs Syndrome

HORIZANT has been studied in adults with restless legs syndrome and is approved by the Food and Drug Administration (FDA) for adults, however it has not been approved by the FDA for teenagers. 

In this study some participants receive HORIZANT and some participants receive a placebo.

For this study you will take 2 tablets of study drug daily for 12 weeks. To find out how well HORIZANT works, 2 different doses of HORIZANT (300 mg or 600 mg) will be compared to placebo, but no one will know until the study is over which study drug a study participant was taking during the study. After completion of this trial, you can continue to the Open Label study, which means all participants receive HORIZANT.

For more information, please contact Caroline Kumm at 716-558-3492.