Clinical Trials Research Miami Campus - Dr. Marc E Agronin, Principal Investigator Name of Study: Acadia (SERENE Study) ACP-103-032 Description of Study: This is a phase II study testing to see if an investigational drug called Pimavanserin can be used to treat agitated and aggressive behavior in individuals with Alzheimer s disease. Indication: Agitation and aggression in Alzheimer s disease Recruiting Subjects Ages: 50 years or older Duration of Study: approximately 3 months 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 Subjects Ages: 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 Subjects Ages: 50 years or older Duration of Study: approximately 6 months
Name of Study: Axovant RVT-101-2003 Description of Study: This is a phase II study testing an investigational medication called Intepirdine (RVT-101) to improve movement problems including gait and balance in individuals with certain forms of dementia. Indication: Gait impairment and Alzheimer s disease, dementia with Lewy bodies, or Parkinson s disease dementia Recruiting Subjects Ages: 50 89 years Duration of Study: approximately 14 weeks 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. Recruiting Subjects Ages: 50-85 years Duration of Study: approximately 18 months Name of Study: Eli Lilly (GERAS-US Study) H8A-US-B004 Description of Study: The GERAS-US Study is collecting information from individuals with mild cognitive impairment or mild dementia due to Alzheimer s disease about the care involved in maintenance and treatment, including use of resources, types of care, and outcomes. The study s goal is to assess the total costs involved in individuals already seeking routine care, and to better understand overall care for earlier stages of the disease. Indication: Early stages of Alzheimer s disease Recruiting Subjects Ages: 55 85 years Duration of Study: 36 months 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. Duration of Study: approximately 29 months
Name of Study: Genentech (GN30009 Study) Description of Study: This study evaluates the use of an investigational imaging tracer, [ 18 F] MNI-798, as a diagnostic tool to identify Tau Tangles, an abnormal buildup of protein in the brain, in patients with prodromal, mild, and moderate Alzheimer s disease. The imaging agent may be used as a marker for disease progression in conjunction with PET imaging, and may allow doctors to see changes in the brains of patient who have problems with thinking and memory related to Alzheimer s disease. Indication: Prodromal, mild, and moderate Alzheimer s disease Recruiting Subjects Ages: 50 80 years Duration of Study: 18 months Name of Study: ACRIN (Imaging Dementia - Evidence for Amyloid Scanning, IDEAS, Study) Description of Study: The IDEAS study is an observational study to determine the impact of amyloid PET scans on patient-oriented outcomes in those with mild cognitive impairment (MCI) or dementia. The study will look at whether knowing a patient s amyloid status significantly impacts long-term patient care and outcome. Amyloid plaques are sticky clumps of protein associated with Alzheimer s disease that can be seen in pictures of the brain. Indication: Dementia or MCI Recruiting Subjects Ages: 65 years or older Duration of Study: approximately 24 months Name of Study: IntraCellular (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 Subjects Ages: 55 years or older Duration of Study: 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 Subjects Ages: 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 Duration of Study: approximately 8 months Name of Study: Roche (CREAD Study) BN29552 - Immunotherapy Description of Study: This is a phase III global study evaluating the efficacy and safety of the investigational medication Crenezumab to assess if targeting beta-amyloid (which is implicated in the pathogenesis of Alzheimer s disease) early in the course of the disease can delay its progression. Indication: Prodromal to mild Alzheimer s disease Duration of Study: approximately 35 months Miami Campus - Dr. Shaun Corbett, Principal Investigator Name of Study: Axsome (CREATE-1 Study) AXS-02-301 Description of Study: The CREATE-1 study is a phase III clinical trial evaluating the effectiveness and safety of an oral investigational medication AXS-02 (zoledronate) to see if it can help reduce lingering upper or lower limb pain in patients with Complex Regional Pain Syndrome (CRPS-1). Indication: Complex Regional Pain Syndrome (CRPS-1) Recruiting Subjects Ages: 18 years or older Duration of Study: 6 to 7 months Aventura Location- Dr. Julie Schwartzbard, 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 Subjects Ages: 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 Subjects Ages: 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. Duration of Study: approximately 29 months If you are interested in participating or learning more about our clinical trials, please call 305-514-8710 ESuarez@miamijewishhealth.org EDiaz1@miamijewishhealth.org