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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06025877
Other study ID # C2N002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 15, 2023
Est. completion date October 30, 2024

Study information

Verified date December 2023
Source C2N Diagnostics
Contact Leslie M Jacobs, CCRP, PMP
Phone 314-464-0002
Email ljacobs@c2n.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18% of people in the United States over age 60 years (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-im pairment. Accessed August 16, 2022). MCI does not substantially interfere with daily activities, although complex functional tasks may be performed less efficiently (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 30% of MCI patients have Alzheimer's disease (AD) as a cause of their symptoms (Lopez,OL, Kuller LH, Becker JT, et al. Incidence of dementia in mild cognitive impairment in the cardiovascular health study cognition study. Arch Neurol. 2007;64(3):416-420.doi:10.1001/archneur.64.3.416)). In contrast, dementia is defined by chronic, acquired loss of two or more cognitive abilities caused by brain disease or injury, often associated with significant interference with the ability to function at work or at usual activities. (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 60-80% of dementia patients have AD as a cause of their symptoms (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-im pairment. Accessed August 16, 2022).


Description:

The Quality Improvement PrecivityAD2(TM) Clinician Survey and Clinical Utility Study (QUIP II) represents a large-scale initiative for the PrecivityAD2 blood test for use by neurologists, geriatricians, and geropsychiatrists (memory care specialists) who see patients aged 55 years and older with signs or symptoms of MCI or dementia. C₂N Diagnostics, LLC is a CLIA-certified, CAP-accredited diagnostic testing laboratory based in St. Louis, MO. Its new test, the PrecivityAD2 blood test, measures plasma amyloid beta (Aβ) peptides 42 and 40 (Aβ42/40) Ratio and phosphorylated tau (p-tau) compared to non-phosphorylated tau (np-tau) at amino acid 217 of the tau peptide (p-tau217/np-tau217) ratio to determine whether a patient with signs or symptoms of cognitive impairment is likely to have brain amyloid plaques, a pathological hallmark of AD.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date October 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers
Gender All
Age group 55 Years and older
Eligibility Physician Inclusion Criteria: 1. Memory care specialists actively practicing in the United States 2. Practice serves individuals with MCI or dementia age > 55 years 3. Average patient volume > 25 visits per week (all patients seen across practice) 4. Memory care specialist with access to an online electronic survey Physician Exclusion Criteria: 1) Clinicians who practice in New York Participant Inclusion Criteria: 1. Individual with MCI or dementia 2. Age >= 55 years Participant Exclusion Criteria 1. Individual requiring test related blood draw within the state of New York 2. Participation does not seem to be in the best interest of the individual, per the ordering clinician

Study Design


Intervention

Other:
PrecivityAD2(TM) blood test
The PrecivityAD2 blood test measures plasma amyloid beta (Aß) peptides 42 and 40 (Aß42/40) Ratio and phosphorylated tau (p-tau) compared to non-phosphorylated tau (np-tau) at amino acid 217 of the tau peptide (p-tau217/np-tau217) ratio to determine whether a patient with signs or symptoms of cognitive impairment is likely to have brain amyloid plaques, a pathological hallmark of AD.

Locations

Country Name City State
United States Josephson Wallack Munshower Neurology, P.C. Indianapolis Indiana
United States Tulane Doctors Neurosurgery Clinic New Orleans Louisiana
United States Sharlin Health and Neurology Ozark Missouri
United States Advocate Memory Center Park Ridge Illinois
United States C2N Diagnostics Saint Louis Missouri
United States UCSF Memory and Aging Center San Francisco California
United States Pacific Brain Health Center Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
C2N Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in planned clinical management (Cohort A and B) The association of the test result on medical decision making Day 20
Primary Change in planned clinical management (Cohort B) Evaluate the planned versus subsequent planned change in clinical management as a result of receiving the test result Day 0 vs Day 20
Primary Difference between the actual age and symptomatology versus intended use criteria (Cohort A and B) Evaluate the intended use criteria Day 90
Secondary Relationship between the test result and actual clinical management (Cohort B) Association of the test result on subsequent conducted changes in clinical management and test results when evaluating individuals with MCI or dementia in an ambulatory setting Day 90
Secondary Change in planned clinical management compared to conducted clinical management (Cohort B only) The evaluation of planned versus conducted change in management as a result of receiving the test result Day 20 vs Day 90
Secondary Change in probability of AD (Cohort A and B) Evaluate the probability of an AD Dx pre and post receipt of the test result Day 0 vs Day 20
Secondary Change in anti-AD medication use (Cohort A and B) Evaluate anti-AD medication use pre- and post-receipt of the test result Day 0 vs Day 20
Secondary Change in diagnosis (Cohort B) Evaluate any changes in diagnoses as a result of receiving the AD test result Day 0 vs Day 90
Secondary Relationship between the test result and planned testing (Cohort B) Evaluate the association between subsequent test ordering pre and post testing Day 0 vs Day 20 vs Day 90
Secondary Correlations between the net promoter score and ease of use by APS2 result (Cohort B) Focus group questions around net promoter score and ease of use, strengths, and limitations of testing Day 90
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