NCT05477056: QUIP I

Quality Improvement PrecivityAD Clinician Survey (QUIP I)

Completed Last updated 20 February 2025

What this trial tests

trial testing PrecivityAD blood test in Alzheimer Disease in 366 participants. Completed in 6 October 2022.

Timeline

1 March 2021

Primary endpoint
6 October 2022

6 October 2022

Quick facts

Lead sponsor	C2N Diagnostics
Status	Completed
Study type	OBSERVATIONAL
Enrollment	366
Start date	1 March 2021
Primary completion	6 October 2022
Estimated completion	6 October 2022
Sites	1 location across United States

Drugs / interventions tested

• PrecivityAD blood test

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Dementia — all drugs for Dementia →
• Cognitive Decline — all drugs for Cognitive Decline →

Sponsor

C2N Diagnostics — full company profile →

Who can join

60 and older, any sex, with Alzheimer Disease or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Blood Biomarkers from Research Use to Clinical Practice: What Must Be Done? A Report from the EU/US CTAD Task Force.
   Angioni D, Delrieu J, Hansson O, Fillit H, et al · · 2022 · cited 97× · PMID 36281661 · DOI 10.14283/jpad.2022.85
2. A blood biomarker test for brain amyloid impacts the clinical evaluation of cognitive impairment.
   Monane M, Johnson KG, Snider BJ, Turner RS, et al · · 2023 · cited 30× · PMID 37550958 · DOI 10.1002/acn3.51863
3. Use of a Blood Biomarker Test Improves Economic Utility in the Evaluation of Older Patients Presenting with Cognitive Impairment.
   Canestaro WJ, Bateman RJ, Holtzman DM, Monane M, et al · · 2024 · cited 21× · PMID 38546435 · DOI 10.1089/pop.2023.0309
4. 15th Conference Clinical Trials Alzheimer’s Disease, November 29- December 2, 2022, San Francisco, CA, USA: Symposia - Oral Communications - Late Breaking Abstracts (Clinical Trial Alzheimer’s Disease)
   · 2022
5. Abstracts from the 11th Canadian Conference on Dementia : Better and Earlier Detection of Dementia in a Changing Landscape; November 2–4, 2023; Toronto, Ontario
   Webster C, Morais J, Gauthier S, Rosa-Neto P, et al · · 2024
6. PATIENT AGE AND SEX DO NOT APPEAR TO INFLUENCE DECISION MAKING AROUND BIOMARKER TESTING FOR COGNITIVE IMPAIRMENT
   · 2023
7. UNDERSTANDING THE RELATIONSHIP BETWEEN AIR QUALITY AND FIVE-YEAR SURVIVAL OF PATIENTS IN THE AMERICAN FAMILY COHORT
   · 2023
8. NATURAL ENVIRONMENTS’ INFLUENCE ON RESPONSIVE BEHAVIOUR, WORK-RELATED STRESS, BURNOUT, AND TURNOVER INTENTION
   · 2023