A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-85
SponsorMerck Sharp & Dohme LLC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MK-2214

    Biological/Vaccine

    IV infusion

  • Placebo

    Drug

    IV infusion

Treatment groups

340 Participants
are divided into 2 treatment groups
Group A: Base and Open-Label Extension Period: MK-2214Experimental treatment 1 intervention
Group B: Base Period: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Base Period: Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr)

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.

Time frame
Baseline, up to approximately 23 months
2

Base Period: Number of Participants Who Experience One or More Adverse Events (AEs)

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.

Time frame
Up to approximately 26 months
3

Base Period: Number of Participants Who Discontinue Study Intervention Due to an AE

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.

Time frame
Up to approximately 23 months

Secondary outcomes

1

Base Period: Change from Baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) Total Score

The CDR-SB is used for cognitive assessment in people with AD. The CDR is a clinical scale that describes 5 degrees of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia CDR score ranging from 0 (normal) to 3 (severe). A total score is calculated as the sum of the category scores, with a range of 0 (normal) to 18 (severe). Higher scores indicate more impairment. The change from baseline in CDR-SB total score will be reported.

Time frame
Baseline, up to approximately 23 months
2

Base Period: Change from Baseline in the Composite Tau PET SUVr in Braak Region III and IV

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). Braak staging ranges from Braak I to VI. Description for Braak III includes amygdala, parahippocampal gyrus, fusiform gyrus, \& lingual gyrus, and Braak IV includes insula, inferior temporal, lateral temporal, posterior cingulate, \& inferior parietal. The composite tau PET SUVr is a weighted average of tau PET SUVr values obtained from multiple brain regions, with weights being the percentage volume of each region within the composite. The change from baseline in composite tau PET SUVr in Braak regions III and IV will be reported.

Time frame
Baseline, up to approximately 23 months
3

Base Period: Change from Baseline in the Composite Tau PET SUVr

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 composite tau PET SUVr is a weighted average of tau PET SUVr values obtained from multiple brain regions, with weights being the percentage volume of each region within the composite. The change from baseline in composite tau PET SUVr will be reported.

Time frame
Baseline, up to approximately 23 months
4

Base Period: Change from Baseline in the Composite Tau PET SUVr in Braak Region I to VI

Participants will have tau PET imaging to assess tau (protein that accumulates in AD \& damages brain cells) pathology. SUVr is SUV in the region of interest, divided by SUV in a reference region (cerebellum). Braak staging ranges from I-VI (Braak I (transentorhinal); II (entorhinal \& hippocampus); III (amygdala, parahippocampal gyrus, fusiform gyrus, \& lingual gyrus); IV (insula, inferior temporal, lateral temporal, posterior cingulate, \& inferior parietal); V (orbitofrontal, superior temporal, inferior frontal, cuneus, anterior cingulate, supramarginal gyrus, lateral occipital, precuneus, superior parietal, superior frontal, \& rostro medial frontal); VI (paracentral, postcentral, precentral, \& pericalcarine)). Composite tau PET SUVr is weighted average of tau PET SUVr values from multiple brain regions, with weights being percentage volume of each region. The change from baseline in composite tau PET SUVr in Braak region I to IV will be reported.

Time frame
Baseline, up to approximately 23 months

Other outcomes

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