Study

Overview

Official Title: A Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2214 in Adults with Mild Cognitive Impairment or Mild-to-Moderate Alzheimer’s Disease

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of MK-2214 in adults with mild cognitive impairment (MCI) or mild-to-moderate Alzheimer’s Disease (AD). The primary hypothesis (Part 1) is that at a generally well tolerated dose level, the true geometric mean concentration at Day 85 of MK-2214 in cerebrospinal fluid is >0.3 nanomolar (nM). Optional healthy older participants (Part 2) may receive MK-2214 at dose levels determined by criteria met in Part 1.

Study Type:

Interventional

Study Phase:

Phase 1

Estimated Enrollment:

48

Study Start Date:

September 2022

Estimated Study Completion Date:

May 2025

Estimated Primary Completion Date:

May 2025

Eligibility

Ages Eligible for Study:

50 years to 80 years

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

CRITERIA

Inclusion Criteria:

Participant is in overall good health based on medical history and laboratory safety tests
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 progression for 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 Criteria:

Based on clinical interview and Columbia-Suicide Severity Rating Scale (C-SSRS), has reported 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 genitourinary abnormalities or diseases
History of clinically significant active neurological disease (except for AD or MCI for participants in Part 1)
History of clinically significant active autoimmune disease requiring ongoing systemic immunosuppressant therapy
History of cancer (malignancy)
History of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
Positive test(s) for Hepatitis B Surface Antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy visit
Has a contraindication to lumbar dural puncture, such as coagulopathy, concomitant anticoagulation beyond low dose aspirin, thrombocytopenia, or other factors that could preclude safe lumbar puncture
Currently receiving or has received aducanumab or another anti-amyloid therapy within 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 study intervention or is scheduled to receive any non-live vaccine through 14 days following the final dose of study intervention. Exception: COVID-19 and influenza vaccines may be administered
Is receiving systemic immunosuppression, including corticosteroids exceeding physiologic replacement doses

Locations

United States Toll Free Number 1-800-770-4674

Glendale, California, 91206
Los Alamitos, California, 90720
Orange, California, 92868
Hallandale Beach, Florida, 33009
Maitland, Florida, 32751
Port Orange, Florida, 32127
The Villages, Florida, 32162
Winter Park, Florida, 32792
Decatur, Georgia, 30030
Princeton, New Jersey, 08540
North Canton, Ohio, 44720

Results

No Study Results Posted

Study Detail

A Study of MK-2214 in Adults with Mild Cognitive Impairment or Mild-to-Moderate Alzheimer’s Disease (MK-2214-002)

Overview

Eligibility

CRITERIA

Locations

Results