Alzheimer DiseasePhase 1NCT05164536
Plasma P-tau2017 and Quantitative Amyloid PET Imaging
A Phase 1 study testing Amyvid in people with Alzheimer Disease, run by Invicro at 1 site in United States.
Trial summary
The overall goal of this protocol is to compare amyloid burden assessed by amyloid PET to plasma P-tau217 levels. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Amyvid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2021to 8 Nov 2022
- Phase
- Phase 1
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Signed and dated written informed consent obtained from the subject.
- Male participants with partners of childbearing potential must commit to the use of 2 methods of contraception, one of which is a barrier method for male participants for the study duration.
- Male participants must not donate sperm for the study duration.
- Willing and able to cooperate with study procedures.
- Males and females.
- Participants aged ≥ 70, inclusive, at the time of Screening.
- Judged to be cognitively normal by an Investigator based on clinical judgment.
Who cannot join
- Subject has received an investigational drug or device within 30 days of enrollment, unless in the opinion of the Investigator such medication or device will not impair subject safety or scientific integrity of the data.
- Contraindication to amyloid PET imaging or blood sampling.
- Have ever received an experimental or approved medication targeting amyloid or tau.
- Prior participation in other research protocols or clinical care in the last year that would result in radiation exposure exceeding the acceptable annual limit established by the U.S. Federal Guidelines (effective dose of 50 mSv, including the procedures in this clinical protocol).
- Pregnancy, lactating or breastfeeding.
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease that in the Investigator's judgment may interfere with the objectives of the study.
- Unsuitable veins for venipuncture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma P-tau2017 and Quantitative Amyloid PET Imaging in a Cognitively Normal Population
The overall goal of this protocol is to compare amyloid burden assessed by amyloid PET to plasma P-tau217 levels.
Read the detailed description
The overall goal of this protocol is to compare amyloid burden assessed by amyloid PET to plasma P-tau217 levels. Other relevant AD-related investigational biomarkers may also be assessed in the provided samples. Apolipoprotein E (ApoE) genetic status will be evaluated with a serum sample.
- Conditions
- Alzheimer Disease
- Being tested
- Amyvid
- Keywords
- AD
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmyvidDrug
Also called [18F]Florbetapir
All participants will undergo a single β-amyloid PET scan with Amyvid.
| Study group | Role | What they receive |
|---|---|---|
| [18F]Florbetapir | Experimental | Participants will undergo amyloid PET imaging with an approved amyloid radiotracer (ie, [18F]Florbetapir (Amyvid™)) to assess β-amyloid neuritic plaque density. Receives: Drug: Amyvid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a database of brain amyloid deposition by region using PET signal-to-noise ratio, SUVr .
Amyloid PET imaging will be used to measure regional brain amyloid deposition in each subject.
Measured: 1 year
Secondary outcomes (1)
Creation of a database of blood P-tau217 and other blood biomarkers.
Blood will be analyzed at Eli Lilly for P-tau217 and ApoE genotype. The analysis will be described in a separate analysis plan.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start27 Aug 2021
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invicro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Russell, Principal investigator, Invicro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164536
- Sponsor's protocol ID
- Plasma P-tau 2017
- Status last verified
- Feb 2023
- First submitted
- 20 Oct 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma P-tau2017 and Quantitative Amyloid PET Imaging in a Cognitively Normal Population
- ClinicalTrials.gov ID
- NCT05164536
- Acronym / sponsor ID
- Plasma P-tau 2017
- Conditions
- Alzheimer Disease
- Keywords
- AD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- InvicroUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 20 Dec 2021 (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.
The overall goal of this protocol is to compare amyloid burden assessed by amyloid PET to plasma P-tau217 levels.
Detailed description
The overall goal of this protocol is to compare amyloid burden assessed by amyloid PET to plasma P-tau217 levels. Other relevant AD-related investigational biomarkers may also be assessed in the provided samples. Apolipoprotein E (ApoE) genetic status will be evaluated with a serum sample.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]Florbetapir | Experimental | Drug: AmyvidParticipants will undergo amyloid PET imaging with an approved amyloid radiotracer (ie, [18F]Florbetapir (Amyvid™)) to assess β-amyloid neuritic plaque density. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Signed and dated written informed consent obtained from the subject.
- Male participants with partners of childbearing potential must commit to the use of 2 methods of contraception, one of which is a barrier method for male participants for the study duration.
- Male participants must not donate sperm for the study duration.
- Willing and able to cooperate with study procedures.
- Males and females.
Key exclusion criteria (7 listed)
- Subject has received an investigational drug or device within 30 days of enrollment, unless in the opinion of the Investigator such medication or device will not impair subject safety or scientific integrity of the data.
- Contraindication to amyloid PET imaging or blood sampling.
- Have ever received an experimental or approved medication targeting amyloid or tau.
- Prior participation in other research protocols or clinical care in the last year that would result in radiation exposure exceeding the acceptable annual limit established by the U.S. Federal Guidelines (effective dose of 50 mSv, including the procedures in this clinical protocol).
- Pregnancy, lactating or breastfeeding.
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 |
|---|---|---|
| AmyvidAlso: [18F]FlorbetapirAll participants will undergo a single β-amyloid PET scan with Amyvid. | Drug | [18F]Florbetapir |
Primary outcome
Creation of a database of brain amyloid deposition by region using PET signal-to-noise ratio, SUVr .
Time frame: 1 year
Amyloid PET imaging will be used to measure regional brain amyloid deposition in each subject.
1 secondary outcome
Creation of a database of blood P-tau217 and other blood biomarkers.
Time frame: 1 year
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 28 Feb 2025.
- Related InformationLink provided by the sponsor.
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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.
David Russell principal investigator
Invicro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amyvid in people with Alzheimer Disease, run by Invicro 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 7 inclusion and 7 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 28 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Creation of a database of brain amyloid deposition by region using PET signal-to-noise ratio, SUVr . (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025.