Enrolling Clinical Research Trials - Miami Jewish Health Systems

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Jan 26, 2018 - the build-up of tau protein detected by the PET scan and the buildup detected by autopsy of the brain in
Enrolling Clinical Trials Miami Campus - Marc E Agronin, MD, Principal Investigator Name of Study: AVANIR 15-AVP-786-301/303 Description of Study: The TRIAD Study is a phase III study evaluating an investigational medication to see if it may reduce agitation in patients with dementia related to Alzheimer’s disease. Indication: Dementia of the Alzheimer’s type Recruiting Participant Age: 50-90 years Duration of Study: approximately 4 months Name of Study: AVID (A16 Study) 18F-AV-1451-A16 Description of Study: The A16 study is testing an investigational imaging dye, 18F-AV-1451, to see if it can be used in PET imaging to identify a build-up of tau protein, an abnormality found in the brains of patients with Alzheimer’s disease. The study will look at the relationship between the build-up of tau protein detected by the PET scan and the buildup detected by autopsy of the brain in end-of-life subjects. Indication: End Stage conditions (life expectancy < 6 months) Recruiting Participant Age: 50 years or older Duration of Study: approximately 6 months Name of Study: BIOGEN (ENGAGE Study) 221AD301 - Immunotherapy Description of Study: The ENGAGE study is a phase III, global study assessing the efficacy and safety of the investigational medication Aducanumab (BIIB037). The goal is to determine whether the medication can slow the progression of symptoms in individuals with early Alzheimer's disease. Indication: Early Alzheimer’s disease Recruiting Participant Age: 50 - 85 years Duration of Study: approximately 18 months

Name of Study: EISAI E2609-G00-301 Description of Study: This is a phase III study, investigating a drug called Elenbecestat (E2609) in individuals with mild cognitive impairment (MCI) due to Alzheimer’s disease or other early stages of mild Alzheimer’s disease. The goal of the study is determine whether the drug reduces the amount of protein buildup in the brain of Alzheimer’s patients, and if the potential reduction would in turn slow the progression of the disease and its associated memory loss. Indication: Early Alzheimer’s disease Recruiting Participant Age: 50 – 85 years Duration of Study: approximately 29 months Name of Study: EISAI E2006-G000-202 Description of Study: This is a phase II study, evaluating if the investigational drug Lemborexant may help people with Alzheimer’s stay asleep at night and stay awake more during the day. Indication: Alzheimer’s and ISWRD (Irregular Sleep Wake Rhythm Disorder) Recruiting participant Age: 60-90 years Duration of Study: approximately 4 weeks Name of Study: GENENTECH GN39763 Description of Study: This is a phase II study, assessing the efficacy and safety of the investigational antibody MTAU993A for the treatment of Alzheimer’s disease, targeting Tau Protein in the brain. Indication: Prodromal to Mild Alzheimer’s disease Recruiting participant Age: 50-80 years Duration of Study: approximately 24 months

Name of Study: INTRACELLUAR (201 Agitation Study) ITI-007-201 Description of Study: This is a phase III clinical trial testing the effectiveness and safety of an investigational medication (ITI-007), on treating symptoms of agitation associated with dementia in patients with probable Alzheimer’s Disease. Indication: Probable Alzheimer’s disease Recruiting Participant Age: 55 years or older Duration of Study: approximately 2 months Name of Study: NEURIM NEUP11-AD2 Description of Study: This is a phase II study evaluating the safety, tolerability, and efficacy of an investigational drug called Piromelatine in patients with mild Alzheimer’s Disease. Piromelatine may have the potential to enhance sleeping quality and patterns, which has been shown to be positively associated with overall cognitive function. Indication: Mild Dementia due to Alzheimer’s disease Recruiting Participant Age: 60 – 85 years Duration of Study: approximately 7 months Name of Study: PROCLARA NPT088-CL002 - Immunotherapy Description of Study: This is a phase I study assessing the safety and tolerability of the investigational drug NPT008 in patients with mild to moderate probable Alzheimer’s disease. The drug is intended to target multiple types of misfolded proteins in the brain of Alzheimer’s patients, all which have been linked to the pathology of neurodegenerative diseases and in combination may contribute to disease progression. Indication: Probable Alzheimer’s disease Recruiting Participant Age: 50 – 85 years Duration of Study: approximately 8 months

Aventura Location- Julie Schwartzbard, MD, Principal Investigator Name of Study: ALLERGAN UBR-MD-02 Description of Study: This is a phase II clinical trial testing the effectiveness and safety of an investigational medication that targets single migraine attacks. The goal of the study is to see if the medication can provide acute treatment for moderate to severe migraines. Indication: Migraine with or without aura Recruiting Participant Age: 18 – 75 years Duration of Study: 2-3 months Name of Study: BIOTIE TOZ-CL06 Description of Study: This is a phase III clinical trial evaluating the safety and efficacy of a medication called Tozadenant, which may potentially decrease daily “Wearing-Off” periods in Levodopa-treated patients with Parkinson’s disease. Indication: Parkinson’s disease (PD) Recruiting Participant Age: 30 – 80 years Duration of Study: Up to 62 weeks Name of Study: EISAI E2609-G00-301 Description of Study: This study is investigating a drug called Elenbecestat (E2609) in individuals with mild cognitive impairment (MCI) due to Alzheimer’s disease or other early stages of mild Alzheimer’s disease. The goal of the study is determine whether the drug reduces the amount of protein buildup in the brain of Alzheimer’s patients, and if the potential reduction would in turn slow the progression of the disease and its associated memory loss. Indication: Early Alzheimer’s disease Recruiting Participant Age: 50 – 85 years Duration of Study: approximately 29 months If you are interested in participating or learning more about our clinical trials, please call 305-514-8710 [email protected] [email protected]