Phase
Condition
Dementia
Memory Loss
Mild Cognitive Impairment
Treatment
MK-2214
Placebo
Clinical Study ID
Ages 50-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant is in overall good health based on medical history and laboratory safetytests
BMI between 18.5 and 35 kg/m^2
Part 1 (MCI and Mild to Moderate AD) Only:
History of cognitive and functional decline with gradual onset and slow progressionfor at least one year before Screening
Have an Mini-Mental State Examination (MMSE) >12 at the prestudy visit
Modified Hachinski Ischemic Score (MHIS) score <4 at the prestudy visit
Exclusion
Exclusion Criteria:
Based on clinical interview and Columbia-Suicide Severity Rating Scale (C-SSRS), hasreported suicidal ideation with intent, with or without a plan or method
History of unstable or poorly controlled endocrine, gastrointestinal (GI),cardiovascular, hematological, hepatic, renal, respiratory, or genitourinaryabnormalities or diseases
History of clinically significant active neurological disease (except for AD or MCIfor participants in Part 1)
History of clinically significant active autoimmune disease requiring ongoingsystemic immunosuppressant therapy
History of cancer (malignancy)
History of significant multiple and/or severe allergies (eg, food, drug, latexallergy), or has had an anaphylactic reaction or significant intolerability toprescription or nonprescription drugs or food
Positive test(s) for Hepatitis B Surface Antigen (HBsAg), hepatitis C antibodies orhuman immunodeficiency virus (HIV)
Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500mL) within 4 weeks prior to the prestudy visit
Has a contraindication to lumbar dural puncture, such as coagulopathy, concomitantanticoagulation beyond low dose aspirin, thrombocytopenia, or other factors thatcould preclude safe lumbar puncture
Currently receiving or has received aducanumab or another anti-amyloid therapywithin the last 6 months
Has a history of receiving biological therapy within 3 months or 5 half-lives (whichever is longer) or any human immunoglobulin preparation within the last year
Has received any non-live vaccine starting from 14 days prior to first studyintervention or is scheduled to receive any non-live vaccine through 14 daysfollowing the final dose of study intervention. Exception: COVID-19 and influenzavaccines may be administered
Is receiving systemic immunosuppression, including corticosteroids exceedingphysiologic replacement doses
Study Design
Connect with a study center
California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007)
Glendale, California 91206
United StatesSite Not Available
Collaborative Neuroscience Research, LLC ( Site 0009)
Long Beach, California 90806
United StatesSite Not Available
Collaborative Neuroscience Research, LLC ( Site 0009)
Los Alamitos, California 90720
United StatesSite Not Available
NRC Research Institute ( Site 0015)
Orange, California 92868
United StatesSite Not Available
Velocity Clinical Research, Hallandale Beach ( Site 0001)
Hallandale Beach, Florida 33009
United StatesSite Not Available
Research Centers of America ( Hollywood ) ( Site 0004)
Hollywood, Florida 33024
United StatesSite Not Available
Charter Research - Lady Lake ( Site 0011)
Lady Lake, Florida 32159
United StatesSite Not Available
K2 Medical Research ( Site 0005)
Maitland, Florida 32751
United StatesSite Not Available
Charter Research - Winter Park ( Site 0012)
Orlando, Florida 32803
United StatesSite Not Available
Progressive Medical Research-Alzheimer's Team ( Site 0013)
Port Orange, Florida 32127
United StatesSite Not Available
Charter Research - Lady Lake ( Site 0011)
The Villages, Florida 32162
United StatesSite Not Available
Charter Research - Winter Park ( Site 0012)
Winter Park, Florida 32792
United StatesSite Not Available
CenExel iResearch, LLC ( Site 0002)
Decatur, Georgia 30030
United StatesSite Not Available
iResearch Atlanta ( Site 0002)
Decatur, Georgia 30030
United StatesActive - Recruiting
Global Medical Institutes LLC; Princeton Medical Institute ( Site 0003)
Princeton, New Jersey 08540
United StatesSite Not Available
Neuro-Behavioral Clinical Research ( Site 0016)
North Canton, Ohio 44720
United StatesSite Not Available
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