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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05477056
Other study ID # C2N001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date October 6, 2022

Study information

Verified date August 2023
Source C2N Diagnostics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There is an important unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and early dementia. MCI impacts 12-18% of people in the United States over age 60 and is often an initial clinical sign of Alzheimer's disease (AD) (Alzheimer's Association, 2022). The PrecivityAD test is an analytically and clinically validated blood test that aids healthcare providers in the diagnosis of AD in patients with MCI and early-stage dementia. C2N has created a quality improvement (QI) survey to gather insight from clinicians as to the clinical effectiveness of the commercially available PrecivityAD™ test, which identifies whether a patient with signs and symptoms of cognitive decline is likely to have amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease.


Description:

By gathering feedback from healthcare providers on patient selection, intended use, and anticipated outcomes and continued or revised care plans as a result of the test report, C2N can better understand the impact of the test results on diagnosis and patient management.


Recruitment information / eligibility

Status Completed
Enrollment 366
Est. completion date October 6, 2022
Est. primary completion date October 6, 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: 1. Memory specialist actively practicing in the United States. 2. Practice includes individuals with mild cognitive impairment age > 60 years 3. Average patient volume > 50 visits per week (all patients seen across practice) Exclusion Criteria: 1. Other clinicians with a specialty outside of the field of Memory Specialists 2. Principal Investigator reserves the right to not include a clinician in the survey

Study Design


Intervention

Other:
PrecivityAD blood test
Clinician Survey post receipt of PrecivityAD blood test result

Locations

Country Name City State
United States C2N Diagnostics Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
C2N Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary evaluate patient selection for the blood test through analysis of clinician survey responses. retrospective analysis of clinician survey data collected during a single timepoint 2021 - 2023
Primary evaluate score interpretation for the Amyloid Probability Score (APS) through analysis of clinician survey responses. retrospective analysis of clinician survey data collected during a single timepoint 2021 - 2023
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