Quality Improvement and Clinical Utility PrecivityAD2(TM) Clinician Survey

Alzheimer Disease Clinical Trial

— QUIP II  

Official title:

Quality Improvement PrecivityAD2(TM): A Survey and Clinical Utility Study of the PrecivityAD2 Blood Test in the Evaluation of Cognitive Impairment (QUIP II)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06025877
• Other study ID #: C2N002
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Memory Impairment
• Mild Cognitive Impairment

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