MK-2214 for Alzheimer's Disease

California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007), Glendale, CA
Alzheimer's DiseaseMK-2214 - Biological
Eligibility
50 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for safety in people with mild memory problems or Alzheimer's. The drug is given at different levels to different groups to find a safe dose. Healthy older adults may also participate.

Eligible Conditions
  • Alzheimer's Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

9 Primary · 0 Secondary · Reporting Duration: Up to approximately 297 days

Day 85
Serum Apparent Terminal Half-Life (t1/2) of MK-2214 After First and Third Dose
Serum Area Under the Concentration-Time Curve of MK-2214 from Time 0 to 28 Hours (AUC0-28) After First and Third Dose
Serum Maximum Concentration (Cmax) of MK-2214 After First and Third Dose
Serum Time to Maximum Concentration (Tmax) of MK-2214 After First and Third Dose
Day 29
Percentage change from baseline to Day 29 in free phospho-tau in CSF
Baseline and Day 85
Percentage change from baseline to Day 85 in free phospho-tau in CSF
Day 85
Concentration of MK-2214 in Cerebrospinal Fluid (CSF) at Day 85 (C85d)
Day 297
Number of Participants Who Experience At Least One Adverse Event (AE)
Day 57
Number of Participants Who Discontinue Study Treatment Due to an AE

Trial Safety

Phase-Based Safety

1 of 3

Trial Design

2 Treatment Groups

MK-2214
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: MK-2214 · Has Placebo Group · Phase 1

MK-2214
Biological
Experimental Group · 1 Intervention: MK-2214 · Intervention Types: Biological
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 297 days

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,736 Previous Clinical Trials
4,973,666 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,669 Previous Clinical Trials
7,959,019 Total Patients Enrolled

Eligibility Criteria

Age 50 - 80 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have experienced a gradual decline in memory and daily functioning for at least a year before the screening.
Your body mass index (BMI) falls between 18.5 and 35 kg/m2.

Who else is applying?

What state do they live in?
California100.0%
What site did they apply to?
California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007)100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "Tried diffrent medication, nothing seems to help"
How many prior treatments have patients received?
0100.0%

Frequently Asked Questions

Are any new participants being accepted into this examination?

"Affirmative, the clinical trial is still in search of participants. Initially published on September 20th 2022, this medical research was last updated on November 15th of that same year (2022)." - Anonymous Online Contributor

Unverified Answer

What potential risks does MK-2214 pose to individuals?

"Due to the limited amount of data regarding MK-2214's safety and efficacy, our team assign this medication a score of 1 on their risk assessment scale." - Anonymous Online Contributor

Unverified Answer

How many locations are overseeing the implementation of this trial?

"This trial is being run out of 8 strategic locations, including Hallandale Beach, Long Beach and Hollywood. To reduce the burden on participants, it is advised to select a clinic close by when enrolling in this study." - Anonymous Online Contributor

Unverified Answer

Does eligibility for this research study extend to those under the age of 30?

"Elderly patients aged between 50 and 80 are currently being recruited for this medical trial." - Anonymous Online Contributor

Unverified Answer

How many volunteers have registered for the trial thus far?

"Affirmative. Clinicaltrials.gov reveals that this medical trial, which initially went live on September 20th 2022, is actively looking for research participants. The experiment requires 48 patients to be recruited from 8 different clinical sites." - Anonymous Online Contributor

Unverified Answer

What is the eligibility criteria for participation in this experiment?

"Alzheimer's Disease sufferers aged 50 to 80 are currently being recruited for this medical trial. To be eligible, participants must demonstrate general good health, have a BMI between 18.5-35 kg/m2, display gradual decline in mental and physical function over the course of one year prior to screening with MMSE scores >12 and <28 as well as MHIS score <4 at the pre-study visit." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.