Clinical Research

Clinical Research & Clinical Trials

Clinical research and clinical trials are conducted to evaluate the effectiveness and safety of medications, medical devices or procedures by studying their effects on human beings. Clinical research trials can be conducted by government agencies such as the National Institutes of Health, researchers affiliated with a hospital or university, independent researchers, or private industry such as pharmaceutical companies. 

Burke Rehabilitation Hospital actively seeks volunteers, also known as study subject to take part in clinical trials. Eligibility to participate in trials is based on pre-determined criteria. Subjects are usually divided into two or more groups, including a control group that does not receive the experimental treatment and receives a placebo instead or receives an already approved treatment for comparison purposes. Government agencies such as the Food and Drug Administration (FDA) either approve or deny approval of new treatments based on the results of clinical trials. Clinical trials are conduced at Burke Rehabilitation Hospital in White Plains, New York.

Advancing Neuro-Rehabilitation Research in Partnership with Burke Neurological Institute
Burke Rehabilitation Hospital has enjoyed a long-standing synergy aiming to advance neuro-rehabilitation research with its partner Burke Neurological Institute, two separate entities sharing one campus. Learn more about novel clinical trials and outpatient clinics including breakthrough robotic-assisted rehabilitation offered at the Burke Neurological Institute here

Restorative Neurology Clinic at Burke Neurological Institute
Burke Rehabilitation Hospital refers patients to the Burke Neurological Institute, an on-campus research partner, to participate in breakthrough robotic-assisted rehabilitation. The Restorative Neurology Clinic at Burke Neurological Institute is a self-pay clinic offering state-of-the-art robotic neuro-rehabilitation therapies for individuals who are recovering from stroke, spinal cord injury, traumatic brain injury, other neurological conditions. Learn more about upper and lower limb robotic programs and clinical trials.

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Search Results

Your search for 'Dementia ' matches these Clinical Studies:

  • Dementia

    Jun 13, 2016 (ongoing)

    A Phase III Safety and Efficacy Study of ALZT-OP1 in Subjects with Evidence of Early Alzheimer’s Disease. Protocol Number AZT-001

    This Phase III study is designed as a randomized, double-blinded, placebo-controlled study for subjects with evidence of early AD. Subjects will be randomly assigned to the Group I arm which will consist of ALZT-OP1a  (cromolyn) for inhalation, plus an oral placebo tablet; OR the Group II arm, which consists of ALZT-OP1 combination therapy ALZT-OP1a (cromolyn) for inhalation, plus ALZTOP1b (ibuprofen) tablet for oral administration; OR to the Group III arm, which will consist of inhaled placebo, plus ALZT-OP1b (ibuprofen) tablet for oral administration; OR to the Group IV placebo arm, which will consist of inhaled placebo plus an oral placebo tablet.

    This is a 72 week double-blind placebo controlled trial. Inclusion criteria includes: 55-79 years of age, Diagnosis of Mild Cognitive Impairment (MCI) positive Amyloid in Cerebral Fluid, and must have a reliable caregiver. Study medication is administered by inhaler 1 x per day. This is a multi-centered trial and is sponsored by the AZ Therapies Inc.

    For more information, click here

    Inclusion criteria includes: 55-79 years of age, Diagnosis of Mild Cognitive Impairment (MCI) positive Amyloid in Cerebral Fluid, and must have a reliable caregiver. 

    Rosanna Cirio, MA
    (914) 597-2476
    rcirio@burke.org

  • Dementia

    Jun 13, 2016 (ongoing)

    A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deuterated [d6]-dextromethorphan hydrobromide[d6-DM]/ quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type

    The objectives of the study are to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in patients with dementia of the Alzheimer’s type.  The diagnosis of probable Alzheimer’s disease will be based on the ‘2011 Diagnostic Guidelines for Alzheimer’s Disease’ issued by the National Institute of Aging (NIA)-Alzheimer’s Association (AA) workgroups. Diagnosis of agitation will be based on the International Psychogeriatric Association (IPA) Agitation Definition.

    This is a 16 week double-blind placebo controlled trial. Inclusion criteria includes: 50-90 years of age, diagnosis of agitation must meet the IPA provisional definition of agitation, MMSE between 6 and 26, and must have a reliable caregiver. Study medication is administered by inhaler 1 x per day. This is a multi-centered trial and is sponsored by AVANIR PHARMACEUTICALS, INC.

    This is a 16 week double-blind placebo controlled trial. Inclusion criteria includes: 50-90 years of age, diagnosis of agitation must meet the IPA provisional definition of agitation, MMSE between 6 and 26, and must have a reliable caregiver. 

    Sharon Singh 
    (914) 597-2308 
    ssingh@burke.org

Archived Projects

  • Dementia

    Sponsoring Agency: National Institute of aging (NIA) and the Alzheimer’s Disease Discovery Foundation (ADDF). | Apr 7, 2015 - Jun 1, 2018

    Benfotiamine in Alzheimer's Disease: A Pilot Study

    Burke Rehabilitation Hospital is currently conducting a clinical trial to evaluate whether increasing brain glucose utilization can slow cognitive decline in patients with Amnestic Mild Cognitive Impairment or mild Alzheimer's disease dementia.

    Thiamine (vitamin B1) is closely linked to glucose metabolism, which is important to maintain memory and cognition. Many thiamine dependent processes are diminished in Alzheimer’s disease and reduced glucose utilization is one of the early symptoms of the development of Alzheimer’s disease. The goal of this trial is to determine if increasing brain thiamine availability with the new investigational drug benfotiamine will minimize the decline in glucose utilization and slow the cognitive decline associated with Alzheimer’s disease.

    Individuals who are at least 60 years old and with a diagnosis of Amnestic Cognitive Impairment or Alzheimer's disease may be eligible for participation. During this study we will give you a complete neurological exam, conduct tests of memory, learning and other cognitive functions, draw blood for laboratory measures, and use imaging to examine the presence of amyloid (plaques) in your brain and also the amount of glucose that your brain is using.

    Study participation will be over a 12 month period and will include follow-up visits to our clinic every 3 months. There are no costs associated with participation in this study.

     Burke Rehabilitation Center is the designated location for this study.  If you would like more information regarding this study, please contact Rosanna Cirio, MA at 914-597-2476 or rcirio@burke.org.

    Gary E Gibson, Ph.D.

    Rosanna Cirio, BS, MS  Burke Rehabilitation Hospital Co-Investigator

    Pasquale Fonzetti M.D. Burke Rehabilitation Hospital Co-Investigator

    Jessica Franchino-Elder Ph.D Winifred Masterson Burke Medical Research Institute  Co-Investigator

    Individuals who are at least 60 years old and with a diagnosis of Amnestic Cognitive Impairment or Alzheimer's disease may be eligible for participation. 

    Rosanna Cirio, MA

    914-597-2476

    rcirio@burke.org

  • Dementia

    Jun 13, 2016 - Feb 22, 2018

    Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study: A Coverage with Evidence Development Longitudinal Cohort Study

    The purpose of the Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study is to examine prospectively how the use of amyloid PET impacts the management and outcomes of patients with mild cognitive impairment (MCI) or dementia of unknown etiology. The Centers for Medicare & Medicaid Services (CMS) is providing coverage for the amyloid PET performed for this project under a program known as “coverage with evidence development” (CED).

    This is a 90 day study.  The Inclusion Criteria includes:  65 and older; Medicare beneficiary; Diagnosis of MCI or dementia verified by a dementia specialist within 24 months; The etiologic cause of cognitive impairment is uncertain after a comprehensive evaluation by a dementia specialist, including general medical and neurological examination, mental status testing including standard measures of cognitive impairment, laboratory testing, and structural neuroimaging. 

    The Inclusion Criteria includes:  65 and older; Medicare beneficiary, Diagnosis of MCI or dementia verified by a dementia specialist within 24 months; The etiologic cause of cognitive impairment is uncertain after a comprehensive evaluation by a dementia specialist, including general medical and neurological examination, mental status testing including standard measures of cognitive impairment, laboratory testing, and structural neuroimaging . 

    Rosanna Cirio, MA
    (914) 597-2476
    rcirio@burke.org

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