NCT04926259

Brief Summary

Alzheimer's disease, Parkinson's disease, and Huntington's disease are common neurodegenerative diseases. Tau is a microtubule-associated protein, and aggregated tau resulting from hyperphosphorylation is a pathological feature of a group of neurodegenerative diseases known as tauopathies. The 18F-T807 (AV1451) molecular probe is a novel molecularly targeted imaging agent that exhibits high affinity and good selectivity for tau.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Nov 2021

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

3.1 years

First QC Date

June 7, 2021

Last Update Submit

November 23, 2021

Conditions

Neurodegenerative Disorders

Outcome Measures

Primary Outcomes (6)

  • standardized uptake value ratio (SUVR)

    the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference

    From right after tracer injection to 2-hours post-injection

  • Aβ42 in CSF

    Aβ42 (amyloid beta isoform 42) is significantly lower in the cerebrospinal fluid of patients with neurodegenerative diseases and is one of the biomarkers used clinically to diagnose neurodegenerative diseases

    Within 2 hours prior to tracer injection

  • t-tau in CSF

    t-tau (total tau) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration

    Within 2 hours prior to tracer injection

  • p-tau in CSF

    p-tau (tau phosphorylated at Thr-181) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration

    Within 2 hours prior to tracer injection

  • NfL in CSF

    NfL (neurofilament light chain) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration

    Within 2 hours prior to tracer injection

  • NfL in the blood

    NfL is significantly increased in the blood of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration

    Within 2 hours prior to tracer injection

Study Arms (1)

18F-T807, PET/CT

EXPERIMENTAL

PET/CT perform after injecting 18F-T807

Drug: 18F-T807

Interventions

18F-T807DRUG

Intravenous injection of one dose of 10mCi (370MBq, ±5%) 18F-T807. Each subject receive a single intravenous injection of 18F-T807, and undergo PET/CT imaging within the specificed time.

18F-T807, PET/CT

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients or their families complain of significant memory impairment;
  • Objective memory impairment (e.g., tests of article identification, recall, delayed memory);
  • Be able to obtain complete diagnosis and treatment records and be able to carry out long-term follow-up;
  • Signed written consent.

You may not qualify if:

  • Psychiatric disorders: including anxiety disorder, affective disorder, severe psychosis, or drug-induced psychosis;
  • Pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Neurodegenerative Diseases

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Shaobo Yao, PhD

CONTACT

86-0591-87981618yaoshaobo008@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nuclear Medicine Department

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 15, 2021

Study Start

November 1, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 26, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)