Phase
Condition
Dementia
Treatment
N/AClinical Study ID
Ages 50-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent form
Stated availability and willingness to comply with all study procedures untilreferred to a clinical trial
Age 50-85 (inclusive)
Global Clinical Dementia Rating (CDR) score of 0 or 0.5 and no diagnosis of dementia
Has a study partner that is willing to participate as a source of information andhas at least weekly contact with the participant (contact can be in-person, viatelephone or electronic communication). The study partner must have sufficientcontact such that the investigator feels the study partner can provide meaningfulinformation about the participant's daily function.
In good general health as evidenced by medical history
Adequate visual and auditory acuity to allow neuropsychological testing
Fluent in English or Spanish
For females who are not surgically sterile or post-menopausal by two years,receiving a Positron Emission Tomography (PET) scan for amyloid biomarkerconfirmation: negative pregnancy test prior to amyloid PET scan
Completed six grades of education or has a good work history
Evidence of elevated or intermediate (subthreshold) levels brain amyloid as assessedby central review of amyloid PET or cerebrospinal fluid (CSF) data. Prior amyloidtesting results may be used with approval from the Coordinating Center.
Exclusion
Exclusion Criteria:
Treatment with an another anti-amyloid investigational anti-amyloid drug or otherexperimental intervention within 12 months. Use of aducanumab or other approvedanti-amyloid treatments allowed if stable for at least 3 months.
Enrolled in another interventional clinical trial within the last 12 weeks
Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson'sdisease, multi-infarct dementia, Huntington's disease, normal pressurehydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder,subdural hematoma, multiple sclerosis, or history of significant head traumafollowed by persistent neurologic deficits or known structural brain abnormalities.
Major depression, bipolar disorder as described in DSM-V within the past 1 year orpsychotic features, agitation or behavioral problems within 3 months, which couldlead to difficulty complying with the protocol
History of schizophrenia (DSM V criteria)
History of alcohol or substance abuse or dependence within the past 2 years (DSM Vcriteria)
Clinically significant or unstable medical condition, including uncontrolledhypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal,hepatic, endocrine, or other systemic disease in the opinion of the Investigator,may either put the participant at risk because of participation in the study, orinfluence the results, or the participant's ability to participate in the study.
History within the last 3 years of a primary or recurrent malignant disease with theexception of non-melanoma skin cancers, resected cutaneous squamous cell carcinomain situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostatecancer with normal prostate-specific antigen post-treatment
Clinically significant abnormalities in B12 or thyroid function tests (TFTs) thatmight interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is notphysiologically significant.
Clinically significant abnormalities in screening laboratories or ECG.
For participants undergoing CSF collection: a current blood clotting or bleedingdisorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g. warfarin)
Participants whom the Site PI deems to be otherwise ineligible.
Study Design
Study Description
Connect with a study center
University of Alabama
Birmingham, Alabama 35294
United StatesSite Not Available
Banner Alzheimer's Institute
Phoenix, Arizona 85006
United StatesSite Not Available
Banner Sun Health Research Institute
Sun City, Arizona 85351
United StatesSite Not Available
University of California, Davis
Davis, California 95616
United StatesSite Not Available
Sun Valley Research Center, Inc
Imperial, California 92251
United StatesSite Not Available
University of California, Irvine
Irvine, California 92697
United StatesSite Not Available
University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
Hoag Pickup Family Neurosciences Institute
Newport Beach, California 92663
United StatesSite Not Available
University of California, San Francisco
San Francisco, California 94143
United StatesSite Not Available
University of California, Davis
Walnut Creek, California 945985900
United StatesSite Not Available
Yale University
New Haven, Connecticut 06510
United StatesSite Not Available
Georgetown University
Washington, District of Columbia 20057
United StatesSite Not Available
Brain Matters Research
Delray Beach, Florida 33445
United StatesSite Not Available
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United StatesSite Not Available
Gonzalez MD & Aswad MD Health Services
Miami, Florida 33125
United StatesSite Not Available
Wien Center for Alzheimer's Disease
Miami Beach, Florida 33140
United StatesSite Not Available
Renstar Medical Research
Ocala, Florida 34470
United StatesSite Not Available
Synexus Clinical Research Orlando
Orlando, Florida 32806
United StatesSite Not Available
Progressive Medical Research
Port Orange, Florida 32127
United StatesSite Not Available
Brain Matters Research
Stuart, Florida 34997
United StatesSite Not Available
University of South Florida - Health Byrd Alzheimer Institute
Tampa, Florida 33613
United StatesSite Not Available
Synexus Clinical Research, The Villages
The Villages, Florida 32162-7116
United StatesSite Not Available
Charter Research, LLC
Winter Park, Florida 32792
United StatesSite Not Available
Emory University
Atlanta, Georgia 30329
United StatesSite Not Available
Columbus Memory Center
Columbus, Georgia 31909
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Rush University
Chicago, Illinois 60612
United StatesSite Not Available
Indiana University
Indianapolis, Indiana 46202
United StatesSite Not Available
University of Kansas
Fairway, Kansas 66205
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40504
United StatesSite Not Available
Johns Hopkins University
Baltimore, Maryland 21224
United StatesSite Not Available
Brigham & Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Headlands Eastern MA LLC
Plymouth, Massachusetts 02360
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48105
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55902
United StatesSite Not Available
Washington University, St. Louis
Saint Louis, Missouri 63130
United StatesSite Not Available
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada 89106
United StatesSite Not Available
Advanced Memory Research Institute of NJ
Toms River, New Jersey 08755
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14620
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Case Western Reserve University
Beachwood, Ohio 44195
United StatesSite Not Available
Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Abington Neurological Associates
Abington, Pennsylvania 19001
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Butler Hospital Memory and Aging Program
Providence, Rhode Island 02906
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
Ralph H. Johnson VA Medical Center
Charleston, South Carolina 29401
United StatesSite Not Available
Roper St. Francis Hospital
Charleston, South Carolina 29401
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
University of North Texas Health Sciences Center
Fort Worth, Texas 76107
United StatesSite Not Available
National Clinical Research, Inc.
Richmond, Virginia 23294
United StatesSite Not Available
University of Washington / Seattle Institute for Biomedical and Clinical Research
Seattle, Washington 98108
United StatesSite Not Available
University of Wisconsin-Madison
Madison, Wisconsin 53792
United StatesSite Not Available

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