Phase
Condition
Lewy Body Dementia
Parkinson's Disease
Parkinson's With Dementia
Treatment
CT1812
Clinical Study ID
Ages 50-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementiawith Lewy Bodies (DLB).
MRI, or CT scan due to contraindication of MRI if approved by medical monitor)obtained during screening consistent with the clinical diagnosis of DLB and withoutfindings of significant exclusionary abnormalities. An historical MRI (or CT scan),up to 1 year prior to screening, may be used if there is no history of interveningneurologic disease or clinical events (such as a stroke, head trauma etc.) and thesubject is without clinical symptoms or signs suggestive of such intervening events.
MMSE 18-27 inclusive
Exclusion
Exclusion Criteria:
Any neurological condition that may be contributing to cognitive impairment aboveand beyond those caused by the subject's DLB, including any co-morbidities detectedby clinical assessment or MRI (or CT scan due to contraindication of MRI, ifapproved by medical monitor)
Screening MRI (or historical MRI or CT scan due to contraindication of MRI ifapproved by medical monitor) or historical MRI/CT scan, if applicable. of the brainindicative of significant abnormality, including, but not limited to, priorhemorrhage or infarct > 1 cm3, >3 lacunar infarcts, cerebral contusion,encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus,space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a smallincidental meningioma is observed, the medical monitor may be contacted to discusseligibility.
Clinical, laboratory findings or medical history consistent with:
Other primary degenerative dementia (fronto-temporal dementia, Huntington'sdisease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
Other neurodegenerative condition (amyotrophic lateral sclerosis, etc.).
Seizure disorder.
Other infectious, metabolic or systemic diseases affecting the central nervoussystem (syphilis, present hypothyroidism, present vitamin B12 or folatedeficiency, other laboratory values etc.).
Any major psychiatric diagnosis, including schizophrenia, bipolar disorder, andcurrent major depressive disorder as per Diagnostic and Statistical Manual of MentalDisorders Fifth Edition
Clinically significant, advanced or unstable disease that may interfere with outcomeevaluations.
Study Design
Study Description
Connect with a study center
Barrow Neurological Institute
Phoenix, Arizona 85013
United StatesSite Not Available
Banner Sun Health Research Institute
Sun City, Arizona 85351
United StatesSite Not Available
University of Arizona - Health Sciences Center
Tucson, Arizona 85724
United StatesSite Not Available
Parkinson's and Movement Disorder Institute
Fountain Valley, California 92708
United StatesSite Not Available
Stanford University
Palo Alto, California 94304
United StatesSite Not Available
Pacific Neuroscience Institute
Santa Monica, California 90404
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
CenExel Rocky Mountain Clinical Research, LLC
Englewood, Colorado 80113
United StatesSite Not Available
New England Institute for Neurology and Headache (NEINH)
Stamford, Connecticut 06905
United StatesSite Not Available
JEM Research Institute
Atlantis, Florida 33462
United StatesSite Not Available
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida 33486
United StatesSite Not Available
University of Miami Miller School of Medicine Comprehensive Center for Brain Health
Boca Raton, Florida 33433
United StatesSite Not Available
Charter Research
Lady Lake, Florida 32156
United StatesSite Not Available
Renstar Medical Research
Ocala, Florida 34770
United StatesSite Not Available
Charter Research
Winter Park, Florida 32792
United StatesSite Not Available
Rush University Medical Center Section of Parkinson Disease and Movement Disorder
Chicago, Illinois 60612
United StatesSite Not Available
IU Health Neuroscience Center, Goodman Hall
Indianapolis, Indiana 46202
United StatesSite Not Available
Josephson Wallack Munshower Neurology, P.C
Indianapolis, Indiana 46256
United StatesSite Not Available
The University of Kansas Alzheimer's Disease Research Center
Fairway, Kansas 66205
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40504
United StatesSite Not Available
Headlands Research Eastern Massachusetts, LLC
Plymouth, Massachusetts 02360
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Columbia University
New York, New York 10032
United StatesSite Not Available
UNC Department of Neurology
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Cleveland Clinic Main Campus
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
Summit Headlands, LLC
Portland, Oregon 97210
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of Texas Southwestern
Dallas, Texas 75390
United StatesSite Not Available
Clinical Trial Network
Houston, Texas 77074
United StatesSite Not Available
University of Virginia Adult Neurology
Charlottesville, Virginia 22903
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesSite Not Available
Evergreen Health Research
Kirkland, Washington 98034
United StatesSite Not Available
Universtiy of Washington Department of Neurology
Seattle, Washington 98104
United StatesSite Not Available
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