Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02621606
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2015-11-20
Brief Title:
11CMK-6884 Positron Emission Tomography PET Tracer Validation Trial MK-6884-001
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Three-Part Trial to Qualify 11CMK-6884 Positron Emission Tomography for Use as a Biomarker for Regional M4 PAM Receptor Density Quantification in the Human Brain
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this open-label 3-part study is to investigate the safety and efficacy of 11CMK-6884 as a positron emission tomography PET imaging agent for quantifying muscarinic 4 M4 positive allosteric modulator PAM receptor density in brain regions of interest The study will enroll healthy participants Parts 1 and 2 and participants with Alzheimers Disease AD Part 3 The primary efficacy hypothesis is that the average intra-subject test-retest T-RT variability of tracer uptake in brain regions of interest is 20
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-6884-001 | OTHER | None | None |
| 2015-001631-20 | EUDRACT_NUMBER | Merck Protocol Number | None |