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Alzheimer DiseasePhase 1NCT03902548

Initial Investigation of [18F]P16-129 in Alzheimer's Disease Patients and Healthy Volunteers

A Phase 1 study testing [18F]P16-129 in people with Alzheimer Disease, run by Five Eleven Pharma, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates the initial safety profile of [18F]P16-129 in healthy volunteers including dosimetry determination, and compares the uptake and kinetics of [18F]P16-129 with the FDA approved drug [18F]florbetapir in the brains of Alzheimer's disease patients. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
[18F]P16-129
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
21 Feb 2018to 2 Nov 2019
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Signed and dated written informed consent. Capacity for consent will be determined using the Alzheimer's Association Guidelines, developed at Johns Hopkins and described in Alzheimer's Association
  • Consensus Recommendation: Research consent for cognitively impaired adults:
  • Guidelines for Institutional Review Boards and Investigators (Alzheimer's Association 2004).
  • Have a study partner able to accompany the subject to all visits and answer questions about the subject.
  • Male or female, > 50 years of age
  • Have a diagnosis of probable AD, according to the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria
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  • The patient has a Mini Mental State Examination (MMSE) score at screening of at least 15 and no greater than 26.
  • Female patients must have had her last natural menstruation at least ≥24 months prior to the Screening Visit or have been surgically sterilized prior to the Screening Visit. Male patients must use two methods of contraception in combination if his female partner is of childbearing potential; OR have been surgically sterilized prior to the Screening Visit.
  • In the opinion of the investigator based on medical history and physical examination, can safely tolerate tracer administration and the scanning procedures.
  • Healthy non-smoking males and females, as determined by medical history, physical examination, vital signs, clinical laboratory tests, and an electrocardiogram.
  • 1.1 Male subjects and their child bearing potential partners must be willing to use a reliable method of birth control for the duration of the study.
  • 1.2 Female subjects who are of childbearing potential must agree to use an adequate method of contraception for the duration of the study.
  • Between 18-45 years old, inclusive.
  • BMI between 18-30 kg/m2 inclusive.
  • Have clinical laboratory test results within the reference ranges for the population or results within acceptable deviations that are not considered by the investigator to be clinically significant.
  • All subjects and their partners of childbearing potential must commit to use two methods of contraception, one of which must be a barrier method, from the time of screening and throughout the study and until follow-up.
  • Less than 195 cm (6 feet and 5 inches) tall in order to accommodate the whole body scanning.
  • Have sufficient venous access.

Who cannot join

  • History or presence of a significant neurological diagnosis (other than AD) that may influence the outcome or analysis of the scan results; examples include but are not limited to stroke, traumatic brain injury, space occupying lesions, major head trauma, and Parkinson's disease.
  • History or presence of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal, metabolic, endocrine, or CNS disease or other medical conditions that are not well controlled, may put the subject at risk, could interfere with the objectives of the study, or make the subject unsuitable for participation in the study for any other reason in the opinion of the principal investigator.
  • The patient has a history of seizures, with the exception of childhood febrile seizures.
  • History of positive HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus / antibodies (anti-HCV)
  • Clinically relevant pathological findings in physical examination, ECG, vital signs, or laboratory values at the screening assessment that could interfere with the objectives of the study.
  • Have current clinically significant cardiovascular disease. The patient has, at the Screening Visit: an abnormal ECG that is, in the investigator's opinion, clinically significant, a QTcF > 470 ms.
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  • Has had or is planning to have exposure to ionizing radiation that in combination with the study-related tracer administrations and scanning procedures would result in a cumulative exposure that exceeds recommended exposure limits.
  • Contraindications of MRI. Incidental findings on MRI scans that are pathognomonic for an active disease or pathological process which requires medical intervention will be exclusionary.
  • History of, or suffers from, claustrophobia or feels that he or she will be unable to lie still on their back in the MRI or PET scanner.
  • Patients who have received an investigational medication within the last 30 days. Additionally, the time between the last dose of the previous experimental medication and enrollment (completion of screening assessments) must be at least equal to 5 times the terminal half-life of the previous experimental medication.
  • Part II - Dosimetry in Healthy Volunteers
  • Are currently enrolled in or discontinued within the last 30 days from a clinical trial involving an investigational drug or device (other than the study drug) or are currently enrolled in any other type of medical research.
  • Are currently experiencing neuropsychiatric illness or severe systemic disease based on history and physical exam.
  • Have participated in other research protocols in the last year such that radiation exposure would exceed the annual limits.
  • Pregnant or nursing women.
  • History of head trauma with prolonged loss of consciousness (>10 minutes) or any neurological condition including stroke or seizure (excluding childhood febrile seizure) or history of migraine headache.
  • History of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal or CNS disease or other medical condition that is capable of constituting a risk factor when taking the study drug.
  • Suffer from claustrophobia and would be unable to undergo PET scanning.
  • Any confirmed significant allergic reactions against any drug, or multiple allergies.
  • Currently uses prescription medications, over-the-counter drugs or herbal remedies such as St. Johns Wort) which cannot be discontinued 14 days (or < 5 half-lives, whichever is longer), prior to the PET scan and throughout the study. Exceptions include daily multiple vitamins.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Medical Institutions

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: A Positron Emission Tomography (PET) Study to Compare the [18F]P16-129 and [18F]Florbetapir for Investigations of Amyloid β Pathology in Subjects With Alzheimer's Disease and Investigate the Biokinetics, Radiation Dosimetry, and Safety of [18F]P16-129 in Healthy Volunteers

This study investigates the initial safety profile of [18F]P16-129 in healthy volunteers including dosimetry determination, and compares the uptake and kinetics of [18F]P16-129 with the FDA approved drug [18F]florbetapir in the brains of Alzheimer's disease patients.

Being tested
[18F]P16-129
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]P16-129Drug

    Also called [18F]D3FSP

    Injection of < 10 mCi [18F]P16-129 followed by PET/CT scanning

Study groups in NCT03902548
Study groupRoleWhat they receive
Brain uptake and kinetics in Alzheimer's patientsExperimentalNot described
Receives: Drug: [18F]P16-129
Dosimetry in healthy volunteersExperimentalNot described
Receives: Drug: [18F]P16-129

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Regional brain uptake of [18F]P16-129 and [18F]florbetapir

    Quantitative estimates of amyloid distribution in brain - SUV and SUVR

    Measured: 30 - 90 minutes post injection

  2. Cumulative organ [18F]P16-129 activity for estimates of radiation absorbed dose and effective dose

    dosimetry

    Measured: 0 - 240 min post injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2019
  2. Study start21 Feb 2018
  3. Primary completion2 Nov 2019
  4. Study completion2 Nov 2019

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03902548
Sponsor's protocol ID
JH-147896
Status last verified
Jul 2021
First submitted
2 Apr 2019
Last updated
20 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Alexoff D, Wong DF, Kuwabara H, Dannals RF, Ploessl K, Kung HF. Head to head comparison of two PET/CT imaging agents, [18F]D3FSP ([18F]P16-129) and [18F]AV45, in patients with alzheimer's disease. EJNMMI Res. 2025 Jun 22;15(1):77. doi: 10.1186/s13550-025-01276-w.

    PubMed 40544409

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]P16-129 in people with Alzheimer Disease, run by Five Eleven Pharma, Inc. 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 18 inclusion and 20 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 Jul 2021. 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?

Regional brain uptake of [18F]P16-129 and [18F]florbetapir (time frame: 30 - 90 minutes post injection). 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 NCT03902548, 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 Jul 2021.

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