Alzheimer DiseaseQUIP INCT05477056
Quality Improvement PrecivityAD Clinician Survey (QUIP I)
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by C2N Diagnostics at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- What is being tested?
- PrecivityAD blood test
- How many people
- 366 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 6 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Memory Specialists actively practicing in the United States were asked to complete the QI 1.0 survey with expertise in caring for patients with mild cognitive impairment and knowledge of Alzheimer's Disease in terms of expertise and volume of patients served. This may include nurse practitioners or physician assistants who work in the field of Memory Disorders.
Who may be able to join
- Memory specialist actively practicing in the United States.
- Practice includes individuals with mild cognitive impairment age > 60 years
- Average patient volume > 50 visits per week (all patients seen across practice)
Who cannot join
- Other clinicians with a specialty outside of the field of Memory Specialists
- Principal Investigator reserves the right to not include a clinician in the survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality Improvement Survey I.0: A Retrospective Data Analysis of Clinician Survey Responses Following the Utilization of the PrecivityADTM Blood Test for the Detection of Alzheimer's Disease Pathology (QUIP I)
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.
Read the detailed 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.
- Being tested
- PrecivityAD blood test
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecivityAD blood testOther
Also called AD
Clinician Survey post receipt of PrecivityAD blood test result
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate patient selection for the blood test through analysis of clinician survey responses.
retrospective analysis of clinician survey data collected during a single timepoint
Measured: 2021 - 2023
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
Measured: 2021 - 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Mar 2021
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- C2N Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim West, Ph.D, Principal investigator, C2N
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477056
- Sponsor's protocol ID
- C2N001
- Acronym
- QUIP I
- Status last verified
- Feb 2025
- First submitted
- 23 Jul 2022
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monane M, Johnson KG, Snider BJ, Turner RS, Drake JD, Maraganore DM, Bicksel JL, Jacobs DH, Ortega JL, Henderson J, Jiang Y, Huang S, Coppinger J, Fogelman I, West T, Braunstein JB. A blood biomarker test for brain amyloid impacts the clinical evaluation of cognitive impairment. Ann Clin Transl Neurol. 2023 Oct;10(10):1738-1748. doi: 10.1002/acn3.51863. Epub 2023 Aug 7.
PubMed 37550958
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement Survey I.0: A Retrospective Data Analysis of Clinician Survey Responses Following the Utilization of the PrecivityADTM Blood Test for the Detection of Alzheimer's Disease Pathology (QUIP I)
- ClinicalTrials.gov ID
- NCT05477056
- Acronym / sponsor ID
- QUIP I / C2N001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- C2N DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Memory Specialists actively practicing in the United States were asked to complete the QI 1.0 survey with expertise in caring for patients with mild cognitive impairment and knowledge of Alzheimer's Disease in terms of expertise and volume of patients served. This may include nurse practitioners or physician assistants who work in the field of Memory Disorders.
Key inclusion criteria (3 listed)
- Memory specialist actively practicing in the United States.
- Practice includes individuals with mild cognitive impairment age > 60 years
- Average patient volume > 50 visits per week (all patients seen across practice)
Key exclusion criteria (2 listed)
- Other clinicians with a specialty outside of the field of Memory Specialists
- Principal Investigator reserves the right to not include a clinician in the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrecivityAD blood testAlso: ADClinician Survey post receipt of PrecivityAD blood test result | Other | – |
Primary outcome
evaluate patient selection for the blood test through analysis of clinician survey responses.
Time frame: 2021 - 2023
retrospective analysis of clinician survey data collected during a single timepoint
evaluate score interpretation for the Amyloid Probability Score (APS) through analysis of clinician survey responses.
Time frame: 2021 - 2023
retrospective analysis of clinician survey data collected during a single timepoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Results publication: PubMed 37550958Monane M, Johnson KG, Snider BJ, Turner RS, Drake JD, Maraganore DM, Bicksel JL, Jacobs DH, Ortega JL, Henderson J, Jiang Y, Huang S, Coppinger J, Fogelman I, West T, Braunstein JB. A blood biomarker test for brain amyloid impacts the clinical evaluation of cognitive impairment. Ann Clin Transl Neurol. 2023 Oct;10(10):1738-1748. doi: 10.1002/acn3.51863. Epub 2023 Aug 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim West, Ph.D principal investigator
C2N
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by C2N Diagnostics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate patient selection for the blood test through analysis of clinician survey responses. (time frame: 2021 - 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05477056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.