The primary objective of the diagnostic study is to analyze the CSF measurements of β-Amyloid (1-42) (Aβ 42) and Phospho-Tau (181P) (pTau) using Elecsys β-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF in the…
ID
Source
Brief title
Condition
- Mental impairment disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The ratio of β-Amyloid (1-42) (Aβ 42) and Phospho-Tau (181P) (pTau) in the
screening samples of the phase 2 clinical trial of 247AD201 (BIIB080)
Secondary outcome
Not applicable
Background summary
This diagnostic study is conducted in association with the pharma phase 2
clinical trial titled *A Randomized, Double-Blind, Placebo-Controlled,
Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of
BIIB080 in Subjects with Mild Cognitive Impairment Due to Alzheimer*s Disease
or Mild Alzheimer*s Disease Dementia (Protocol Number: 247AD201)*. In this
pharmaceutical trial, the drug BIIB080 is being investigated in adult subjects
with mild cognitive impairment (MCI) due to AD or mild AD mild AD dementia.
Roche Diagnostics has developed diagnostic biomarker assays to measure the β-
Amyloid (1-42) and Phospho-Tau (181P) levels in CSF (cerebrospinal fluid)
samples. The ratio between β-Amyloid (1-42) and Phospho-Tau (181P) is evidence
for amyloid pathology, one of the hallmarks of Alzheimers Disease (AD). Based
on the ratio between β-Amyloid (1-42) and Phospho-Tau (181P) in CSF screening
samples patients will be included in the pharmaceutical trial.
Moses II is the code name for the diagnostics study in support of the pharma
phase 2 clinical trial.
Study objective
The primary objective of the diagnostic study is to analyze the CSF
measurements of β-Amyloid (1-42) (Aβ 42) and Phospho-Tau (181P) (pTau) using
Elecsys β-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF in the
screening samples of the phase 2 clinical trial of 247AD201 (BIIB080) to enroll
patients based on the pTau/Aβ 42 ratio as evidence of amyloid pathology.
Study design
Clinical Utility Study (Interventional Study according to IVDR)
Intervention
Not applicable, CSF samples will be obtained from patients under the pharma
protocol.
Study burden and risks
There is no direct personal benefit to participating in the performance (Moses
II) study. Patients are not paid for participation in the performance study.
There is minimal/no risk associated with testing the CSF sample; the patient
does not have to undergo any new procedures to have his/her CSF sample tested.
However, the information obtained by testing the CSF sample may partially
determine the patient's eligibility to participate in the pharmaceutical study.
Forrenstrasse 2
Rotkreuz 6343
CH
Forrenstrasse 2
Rotkreuz 6343
CH
Listed location countries
Age
Inclusion criteria
In the present study, CSF samples collected for screening for the associated
pharma trial will be measured. No further patient inclusion criteria apply.
Specifically, the CSF samples will be collected from subjects with either MCI
due to AD or mild AD dementia who meet the screening criteria as described in
the pharma phase 2 clinical trial protocol and are able to undergo CSF sampling
at screening. Please see the pharma clinical trial protocol for patient
inclusion and exclusion criteria for the clinical trial.
Approximately 600 subjects will be screened via CSF in order to test for
eligibility and randomize the planned quantity of subjects in the pharma trial.
CSF specimen eligibility criteria for the performance study:
- frozen at sample receipt
- not visibly hemolyzed
- approx. 500µl sample volume
Exclusion criteria
In the present study, CSF samples collected for screening for the associated
pharma trial will be measured. No further patient exclusion criteria apply.
CSF specimen eligibility criteria for the performance study:
- frozen at sample receipt
- not visibly hemolyzed
- approx. 500µl sample volume
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83517.000.23 |