Clinical Trials in Spain / NCT07033494
Recruiting
Phase 2
A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
NCT07033494 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Early Alzheimer's Disease
Investigational drug(s) / intervention(s)
MK-2214Placebo
MK-2214: IV infusion
Placebo: IV infusion
Study summary
Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD.
The goals of the study are to learn:
* If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.
* About the safety of MK-2214 and if people tolerate it
Eligibility
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD)
* Has a designated study partner who can fulfill the requirements of this study
* If on an approved AD therapy for symptomatic AD, the dosing regimen must have been stable for 3 months prior to screening
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has a known history of stroke or cerebrovascular disease
* Has diagnosis of a clinically relevant central nervous system disease other than AD or other condition that negatively impacts cognition or cognitive status chronically
* Has structural brain disease
* Has a history of seizures or epilepsy within 5 years before screening
* Has any other major central nervous system trauma, or infections that affect brain function
* Has major medical illness or unstable medical condition within 3 months before screening
* Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality
* Has any immunological disease, which is not adequately controlled, or which requires treatment with biologics and/or immunosuppressants during the study
* Has a bleeding disorder that is not under adequate control
* Has a history of malignancy occurring within 5 years of screening
* Has a risk factor for corrected QT interval (QTc) prolongation
* Has liver disease
* Is unwilling or unable to undergo computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scan
* Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision
Primary outcome measure(s)
- Base Period: Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr) — Baseline, up to approximately 23 months
Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD \& damages brain cells. SUVr is SUV in the region of interest divided by SUV in a reference region (cerebellum). The change from baseline in tau PET SUVr will be reported. - Base Period: Number of Participants Who Experience One or More Adverse Events (AEs) — Up to approximately 26 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience one or more AEs will be reported. - Base Period: Number of Participants Who Discontinue Study Intervention Due to an AE — Up to approximately 23 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Trial sites (80)
| Facility | City | Region | Status |
|---|---|---|---|
| Irvine Clinical Research ( Site 1041) | Irvine | California | Recruiting |
| Healthy Brain Clinic ( Site 1005) | Long Beach | California | Recruiting |
| Inglewood Clinical ( Site 1062) | Los Angeles | California | Recruiting |
| Anderson Clinical Research ( Site 1024) | Redlands | California | Recruiting |
| UCSF Memory and Aging Center ( Site 1031) | San Francisco | California | Recruiting |
| Syrentis Clinical Research ( Site 1001) | Santa Ana | California | Recruiting |
| Yale University, Alzheimer's Disease Research Unit ( Site 1059) | New Haven | Connecticut | Recruiting |
| JEM Research Institute ( Site 1046) | Atlantis | Florida | Recruiting |
| Neuropsychiatric Research Center of Southwest Florida ( Site 1003) | Fort Myers | Florida | Recruiting |
| K2 Medical Research ( Site 1047) | Maitland | Florida | Recruiting |
| ClinCloud LLC ( Site 1039) | Melbourne | Florida | Recruiting |
| Indago Research and Health Center Inc ( Site 1044) | Miami Lakes | Florida | Recruiting |
| Aqualane Clinical Research ( Site 1035) | Naples | Florida | Recruiting |
| Suncoast Clinical Research ( Site 1007) | New Port Richey | Florida | Recruiting |
| Renstar Medical Research ( Site 1012) | Ocala | Florida | Recruiting |
| Charter Research - Orlando ( Site 1051) | Orlando | Florida | Recruiting |
| Axiom Brain Health ( Site 1029) | Tampa | Florida | Recruiting |
| K2 Medical Research ( Site 1020) | Tampa | Florida | Recruiting |
| Charter Research - Lady Lake ( Site 1019) | The Villages | Florida | Recruiting |
| Conquest Research LLC ( Site 1053) | Winter Park | Florida | Recruiting |
| CenExel iResearch, LLC ( Site 1015) | Decatur | Georgia | Recruiting |
| Alexian Brothers Medical Center-Neurosciences ( Site 1017) | Elk Grove Village | Illinois | Recruiting |
| Boston Center for Memory ( Site 1008) | Newton | Massachusetts | Recruiting |
| Clinical Research Professionals ( Site 1004) | Chesterfield | Missouri | Recruiting |
| The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064) | Ridgewood | New Jersey | Recruiting |
| The Cognitive and Research Center of NJ ( Site 1057) | Springfield | New Jersey | Recruiting |
| CenExel- AMRI ( Site 1018) | Toms River | New Jersey | Recruiting |
| Alzheimer Disease Research Center (ADRC) ( Site 1000) | Albany | New York | Recruiting |
| Mid Hudson Medical Research ( Site 1050) | New Windsor | New York | Recruiting |
| Basil Clinical ( Site 1065) | Queens | New York | Recruiting |
| AMC Research, LLC ( Site 1006) | Matthews | North Carolina | Recruiting |
| Insight Clinical Trials ( Site 1011) | Independence | Ohio | Recruiting |
| Neuro-Behavioral Clinical Research ( Site 1028) | North Canton | Ohio | Recruiting |
| Flourish Research ( Site 1048) | Plymouth Meeting | Pennsylvania | Recruiting |
| Gadolin Research ( Site 1032) | Beaumont | Texas | Recruiting |
| Horizon Clinical Research Center - Houston ( Site 1026) | Cypress | Texas | Recruiting |
| Organizacion Medica de Investigacion ( Site 0401) | Ciudad de Buenos Aires | Buenos Aires F.D. | Recruiting |
| Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0404) | Ciudad de Buenos Aires | Buenos Aires F.D. | Recruiting |
| Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400) | Caba | Argentina | Recruiting |
| Southern Neurology ( Site 0306) | Kogarah | New South Wales | Recruiting |
+ 40 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in Spain
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07033494 on ClinicalTrials.gov ↗ ← All trials in Spain