Open Alzheimer's Clinical Trials

Mild Cognitive Impairment (MCI) / Early Alzheimer’s Disease

IRB number	IRB18-1580
Title	The AMARANTH Clinical Trial Research Study
Site Principal Investigator	James Mastrianni, MD, PhD Clinical Trials Coordinator: Breanna Bertacchi, BA
Purpose	The University of Chicago Memory Center for Comprehensive Care and Research on Memory Disorders is currently enrolling individuals ages 55 to 85 years, with early Alzheimer’s disease (patients with mild cognitive impairment due to Alzheimer’s disease and patients diagnosed with mild dementia of the Alzheimer’s type) to participate in the clinical trial AMARANTH to help us examine an investigational drug that may have some effect on the brain changes associated with Alzheimer’s disease.
Eligibility	Be between 55 and 85 years old Have either: Experienced gradual and progressive change in memory function over more than 6 months (the study team will assess whether this is due to Alzheimer’s disease) OR Been diagnosed with mild Alzheimer’s disease or mild cognitive impairment (MCI) Have a relative, friend or caregiver who would be willing to be your study partner throughout the study.
Funding	APDM Wearable Technologies, Pfizer, Biogen
Duration	The study will last for approximately 24 months (about 8 weeks to see if you qualify, plus 2 years of treatment, then 4-6 weeks of follow-up).
Contact Name	Breanna Bertacchi
Phone/Email	773-834-1688 / bbertacchi1@neurology.bsd.uchicago.edu
Status Accrual	Active, recruiting

IRB number	IRB18-1346
Title	A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease
Site Principal Investigator	James A. Mastrianni
Purpose	This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 104. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.
Eligibility	50 Years to 90 Years Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment [MCI]) Evidence of the AD pathological process, as confirmed by CSF or amyloid PET scan Demonstrated abnormal memory function MMSE score great than or equal to 22 (≥ 22) Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0 Availability of a reliable study partner who accepts to participate in study procedures throughout the 2 years duration of study If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to baseline and until randomization. For enrollment in the China extension, patients must have residence in mainland China, Hong Kong, or Taiwan and be of Chinese ancestry. Key Exclusion Criteria: Any evidence of a condition other than AD that may affect cognition History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function History or presence of clinically evident cerebrovascular disease At risk for suicide in the opinion of the investigator Patients with evidence of folic acid deficiency Alcohol and/or substance abuse or dependents in past 2 years Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities Any contraindications to brain MRI Unstable or clinically significant cardiovascular, kidney or liver disease Uncontrolled hypertension Related Conditions Alzheimer's Disease
Sponsor	Hoffmann-La Roche
Duration	The study will last for approximately 24 months (about 8 weeks to see if you qualify, plus 2 years of treatment, then 4-6 weeks of follow-up).
Contact Name	Mildred Valentine
Phone/Email	(773) 702-9812 / mvalenti@neurology.bsd.uchicago.edu
Status Accrual	Active, recruiting

IRB number	IRB18-1580
Title	Imaging Dementia Evidence for Amyloid Scanning (IDEAS) Study Mild Cognitive Impairment (MCI)
Site Principal Investigator	James Mastrianni, MD, PhD Co-Principal Investigator: Daniel Applebaum, MD Clinical Trials Coordinator: Breanna Bertacchi, B
Purpose	The purpose of the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Study is to examine how brain imaging helps guide your doctor in how to treat your mild cognitive impairment, and whether these changes in your treatment plan lead to better health outcomes. A one-time brain imaging, called the amyloid PET (positron emission tomography) scan, will be requested by your doctor as part of your standard of care. The amyloid PET brain imaging will look at the build-up of amyloid plaques in the brain which has been linked with Alzheimer’s disease and other related diseases. The brain imaging is not being performed as part of the research; the actual part of the research study is to examine whether the imaging guides your medical treatment and improves health outcomes.
Eligibility	Be 65 years or older Be a Medicare beneficiary Have a diagnosis of mild cognitive impairment (MCI) or dementia (will be determined by The Memory Center) and have Alzheimer’s disease as a diagnostic consideration Meet additional study criteria Medicare will pay for your amyloid PET imaging exam as a covered benefit.
Funding	Alzheimer’s Association in collaboration with the American College of Radiology, and the American College of Radiology Imaging Network (ACRIN).
Contact Name	Breanna Bertacchi
Phone/Email	773-834-1688 / bbertacchi1@neurology.bsd.uchicago.edu
Status Accrual	Soon to be open for enrollment