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 |
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 |
|
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
Key Exclusion Criteria:
Related Conditions |
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 |
|
Phone/Email |
|
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 |
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 |