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

NCT03902548 | Completed Phase 1 FDA Drug

• 1 other identifier: JH-147896
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

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

  Quantitative estimates of amyloid distribution in brain - SUV and SUVR

  30 - 90 minutes post injection

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

  dosimetry

  0 - 240 min post injection

Study Arms (2)

Brain uptake and kinetics in Alzheimer's patients

EXPERIMENTAL

Drug: [18F]P16-129

Dosimetry in healthy volunteers

EXPERIMENTAL

Drug: [18F]P16-129

Interventions

[18F]P16-129 DRUG

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

Also known as: [18F]D3FSP

Brain uptake and kinetics in Alzheimer's patients; Dosimetry in healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.
• 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
• Healthy non-smoking males and females, as determined by medical history, physical examination, vital signs, clinical laboratory tests, and an electrocardiogram.
• 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.
• 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.

Sponsors & Collaborators

• Five Eleven Pharma, Inc.: lead

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 40544409 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

(18 F)D3FSP

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: February 21, 2018
• Primary Completion: November 2, 2019
• Study Completion: November 2, 2019
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

US (1)