Phase
Condition
Memory Loss
Alzheimer's Disease
Learning Disorders
Treatment
Biomarker Data Collection
MK6240
Clinical Study ID
Ages 60-90 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pre-screening Inclusion Criteria
Participants must meet ALL of the following criteria to progress to Visit 1 (Screening):
Participant is between 60 to 90 years of age (inclusive) at the time of consent; and
Participant has a study partner who has sufficient and frequent contact with theparticipant (defined as at least 8 hours of contact a week) and is able to provideaccurate information regarding the participant's cognitive and functional abilities.
Core Study Inclusion Criteria
Participants must meet ALL of the following criteria, in addition to the Pre-screening Inclusion Criteria, for entry into the study:
Participants must provide written consent in the IRB-approved or Ethics Committee (EC) approved informed consent form or have a legally authorized representative (LAR) provide written consent on the participant's behalf in accordance with localand national guidance and regulation;
Participants must be willing to undergo an MRI brain scan within 90 days and anamyloid and tau PET scan within 120 days of signing informed consent;
Participants must be willing to comply with all study 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 study site;
Participants must be willing to be contacted for possible participation in clinicalresearch trials once their participation in this study ends; and
Participants must have a Mini-Mental State Exam (MMSE) score of 16 to 30 inclusiveat screening.
Exclusion
Exclusion Criteria:
Pre-screening Exclusion Criteria
Participants who meet ANY of the following criteria will not be eligible to progress to Visit 1 (Screening):
Participant is unable to undergo amyloid and tau PET scans due to self-reportedpregnancy, sensitivity to ligands being used, poor venous access, contraindicationto PET, or planned or recent exposure to ionizing radiation that in combination withthe planned administration of amyloid radioligand would result in a cumulativeexposure that exceeds recommended local guidelines;
Participants who have reported or have a known negative amyloid PET scan in the past 6 months;
Participants with any known contraindication to brain MRI scan;
Participants with history of stroke or seizures within 1 year of the Pre-ScreeningVisit;
Participants with history of cancer within the past 5 years with the exception ofnon-melanoma skin cancer or prostate cancer in situ;
Participants with known or suspected alcohol or drug abuse or dependence within 1year of the Pre- Screening Visit;
Participants who report any current unstable psychiatric symptoms that couldinterfere with study procedures or impact study data (e.g., uncontrolleddepression);
Participants who have received any potential disease modifying AD treatment within 6months prior to the Pre-screening Visit; and
Participants with known history or self-report to be Human Immunodeficiency Virus (HIV) Positive unless controlled by antiviral medication.
Core Study Exclusion Criteria
Participants who meet ANY of the following criteria, in addition to the Pre-screening Exclusion Criteria, will not be eligible to enroll into the study:
Participants who, in the opinion of the Site Principal Investigator, have serious orunstable medical conditions that would prohibit their completion of all studyprocedures and data collection;
Participants who have serious or unstable medical conditions that would likelypreclude their participation in an interventional research trial;
Participants with self-reported, untreated conditions such as vitamin B12 or folatedeficiency or bladder infections that in the opinion of the Site PrincipalInvestigator could contribute to cognitive impairment;
Participants who have completed cognitive testing within 1 month of Visit 1 (Screening) where the Site Principal Investigator believes the participant'sexposure may cause practice effect;
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) as deemedsignificant by the Site Principal Investigator;
Participants with a Geriatric Depression Scale (GDS) score greater than or equal to 8 at Visit 1 (Screening) and is deemed to be clinically significantly depressed bythe Site Principal Investigator;
Participants with a Rey Auditory Verbal Learning Test (RAVLT) t-score of ≥ 1.2standard deviation above the mean. For non-African Americans, calculateage-sex-education adjusted t-scores. For African American participants, use theMOANS to calculate the age-education adjusted t-scores;
Participants weighing less than 110 pounds;
Participants who are direct employees or family members of direct employees of theparticipating 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; and
For participants completing the RetiSpec retinal scan: Those with a known history ofcontraindication or allergy to Tropicamide 1% (pupil dilation drop).
Longitudinal Sub-Study Eligibility
Inclusion Criteria:
Participants must meet ALL of the following criteria for entry into the sub-study:
Participants who completed the Bio-Hermes-002 Core Study;
Are willing to complete phone call visits with site staff every three months andreturn to the clinic for an annual evaluation; and
Are willing to complete annual PET scans for both amyloid and tau scans.
Exclusion Criteria:
Participants who meet ANY of the following criteria will not be eligible for entry into the sub-study:
Those who are enrolled or intend to enroll into a clinical trial for Alzheimer'sdisease with a potential disease-modifying intervention;
Participants who have serious or unstable medical conditions that would likelypreclude their participation in an interventional research trial;
Those who intend to use medications outside clinical research studies approved byregulatory authorities to modify Alzheimer's disease pathology.
Study Design
Connect with a study center
JEM Research Institute
Atlantis, Florida 33462
United StatesActive - Recruiting
Visionary Investigators Network
Aventura, Florida 33180
United StatesActive - Recruiting
K2 - Winter Garden
Clermont, Florida 34711
United StatesActive - Recruiting
Brain Matters Research
Delray Beach, Florida 33445
United StatesActive - Recruiting
Neuropsychiatric Research Center of SW Florida
Fort Myers, Florida 33912
United StatesActive - Recruiting
K2 Medical Research
Maitland, Florida 32751
United StatesActive - Recruiting
Clincloud
Melbourne, Florida 32940
United StatesActive - Recruiting
Visionary Investigators Network
Miami, Florida 33133
United StatesActive - Recruiting
Charter Research
Orlando, Florida 32803
United StatesActive - Recruiting
Progressive Medical Research
Port Orange, Florida 32127
United StatesActive - Recruiting
Intercoastal Medical Group, Inc.
Sarasota, Florida 34239
United StatesActive - Recruiting
Axiom Brain Health
Tampa, Florida 33609
United StatesActive - Recruiting
Conquest Research
Winter Park, Florida 32789
United StatesActive - Recruiting
Flourish Research - Chicago
Chicago, Illinois 60640
United StatesActive - Recruiting
Quest Research Institute
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
ADRC of Albany
Albany, New York 12208
United StatesActive - Recruiting
Neuro-Behavioral Clinical Research Inc.
North Canton, Ohio 44720
United StatesActive - Recruiting
Flourish Research - Philadelphia
Philadelphia, Pennsylvania 19462
United StatesActive - Recruiting
Gadolin Research LLC
Beaumont, Texas 77702
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.