Phase
Condition
Mild Cognitive Impairment
Memory Loss
Learning Disorders
Treatment
Prescreener database
Clinical Study ID
Ages 50-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants and/or a legally authorized representative (LAR) must providesigned and dated informed consent and authorization to use personal healthinformation in accordance with local and national guidance and regulations;
Male or female 50 to 90 years of age (inclusive) at the time of consent;
Participants must have a Mini-Mental State Exam (MMSE) score of 20 to 28inclusive;
Progressive cognitive complaints must be reported by participant or caregiver;
Participants must be willing to comply with all procedures as outlined in theinformed consent, including blood sampling, genetic testing, and storage ofbiospecimens for future research;
Fluency in the language of the tests used at the site;
Participants must be interested in participating in clinical research.
Exclusion
Exclusion Criteria:
Participants who, in the opinion of the Investigator, have serious or unstablemedical conditions that would prohibit their completion of all prescreeningprocedures and data collection;
Participants who are currently enrolled in another clinical study.
Participants who have serious or unstable medical conditions that would likelypreclude their participation in an interventional research trial;
Participants who have reported or have a known negative amyloid PET scan in thepast 24 months;
Participants with history of stroke within 6 months of prescreening;
Participants with an uncontrolled seizure disorder, unexplained blackouts, ORhistory of a seizure within 6 months (subjects with a history of pediatricfebrile seizure, benign rolandic epilepsy may participate);
Participants with a history or evidence of a malignancy within the 2 yearsprior to prescreening. Subjects with indolent malignancies (e.g., basal cellcarcinoma or squamous cell carcinoma) or malignancies considered to be curedand not actively treated with anti-cancer therapy or radiotherapy are permittedto enroll;
Participants with known or suspected alcohol or drug abuse or dependence within 2 years of prescreening;
Participants with a reported suicidal attempt within 2 years of prescreening),or any unstable psychiatric symptoms (e.g., uncontrolled depression);
Participants who have participated in a clinical trial of any potential diseasemodifying AD treatment and received active drug within 6 months prior toprescreening;
Participants who have any neurological disorder affecting the central nervoussystem, other than AD, that may be contributing to cognitive impairment (e.g.,Parkinson's disease, other dementias, multiple concussions or seizures) asdeemed significant by the Investigator;
Participants with known history of hepatitis C virus, hepatitis B virus, humanimmunodeficiency virus (HIV) or other immunodeficiencies;
Participants that have previously been consented to this protocol;
Participants with a hypersensitivity to mAb treatments, protein derived from amAb, or immunoglobulin therapy;
Participants with allergies to diphenhydramine, epinephrine, andmethylprednisolone;
Participants who are direct employees or family members of direct employees ofthe participating investigators' sites;
Participants who are direct employees of the Sponsor;
Participants who, in the opinion of the Investigator, are unable to completecognitive testing due to inadequate visual or auditory acuity.
Study Design
Connect with a study center
OCT Research
Kelowna, British Colombia V1V 1Z9
CanadaSite Not Available
Pacific Research Network
San Diego, California 92103
United StatesSite Not Available
Syrentis Clinical Research
Santa Ana, California 92705
United StatesSite Not Available
Visionary Investigator's Network
Aventura, Florida 33180
United StatesSite Not Available
Charter Research
Lady Lake, Florida 32159
United StatesSite Not Available
JEM Research Institute
Lake Worth, Florida 33462
United StatesSite Not Available
ClinCloud, LLC
Maitland, Florida 32751
United StatesSite Not Available
K2 Medical Research
Maitland, Florida 32751
United StatesSite Not Available
Merritt Island Medical Research
Merritt Island, Florida 32952
United StatesSite Not Available
Renstar Medical Research
Ocala, Florida 34471
United StatesSite Not Available
ClinCloud, LLC
Viera, Florida 32940
United StatesSite Not Available
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida 33407
United StatesSite Not Available
Charter Research
Winter Park, Florida 32792
United StatesSite Not Available
Conquest Research
Winter Park, Florida 32789
United StatesSite Not Available
iResearch
Decatur, Georgia 30030
United StatesSite Not Available
Quest Research Institute
Farmington Hills, Michigan 48334
United StatesSite Not Available
IPS Research
Oklahoma City, Oklahoma 73106
United StatesSite Not Available
Clinical Trials of Texas
San Antonio, Texas 78229
United StatesSite Not Available
Re:Cognition Health
Fairfax, Virginia 22031
United StatesSite Not Available
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