Topography Staging and Dual Phase Image Quantification of Tau PET in Cognitive Impairment Subjects

NCT04169126 | Unknown Phase 2

• 1 other identifier: 201801834A0
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

A second-generation tau PET image tracer 18F-PM-PBB3 (APN-1607 or MNI-958) has been developed by National Institute of Radiological Sciences. The new tracer solved the off-target binding issue. This study will evaluate new quantitative methods with PMPBB3, by utilized dual phase scanning protocol to extract blood flow and Tau protein binding information, to evaluate appropriate reference brain regions, to improve the normalization efficiency of brain imaging, and to establish a brain template image analysis platform.

Conditions

Alzheimer's Disease

Keywords

Dementia; Tau PET scan; Tau neurofibrillary tangles; Amyloid deposition

Outcome Measures

Primary Outcomes (1)

• Tau Distribution Among Normal, Prodromal AD and AD Dementia Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-PM-PBB3 tau PET Scan.

  4 years

Study Arms (1)

F-18-PMPBB3

EXPERIMENTAL

F-18-PMPBB3 imaging

Drug: F-18 PMPBB3

Interventions

F-18 PMPBB3 DRUG

The study will enroll 200 patients with prodromal AD and AD dementia and 100 normal controls, men and women aged 55-80 years across core clinical criteria of prodromal AD and mild AD dementia based on IWG-2 criteria.

F-18-PMPBB3

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects
• Age between 55-80 years
• Written informed consent must be obtained before any assessment is performed.
• Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to use a barrier contraception method for the duration of the study.
• Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration.
• Male subjects must not donate sperm for the study duration.
• Willing to undergo repeated MRIs and at least two PET scans.
• Patient with Prodromal AD or AD dementia
• Patients fulfill the criteria of prodromal AD or AD dementia based on IWG-2 criteria
• Able to provide written informed consent with reliable carer in AD population. The participant should have reading ability OR 6/more years of formal education OR with working experiences.
• Cognitive normal control
• Cognitive unimpaired individual is defined as normal control in this study. Cognitive un-impaired normal control is defined as cognitive performance in the non-impaired range for that individual, defined as not mild cognitive impairment or demented).
• The normal control should have their clinical dementia rating score 0
• Cognitive Ability Screening Instrument (CASI) scores rated \>50 percentile.

You may not qualify if:

• Already receive outpatient clinic follow-ups with diseases that may affect the cognitive evaluation or presentation that include but not limited to Parkinsonism, Parkinson's disease dementia, schizophrenia, major depression, epilepsy, alcohol or drug abuse, major head trauma with consciousness loss
• Severe progressive or unstable systemic disease that may interfere with the follow-up and test results. These included but not limited to cancer in the past 5 years, end stage renal or liver dysfunction, clinical significant myocardial infarction (New York Heart Association Functional Classification III-IV), Active disease that received admission in the past one year and unstable angina. Other diseases that were not listed but may interfere with the follow-up or test will be judged by the principle investigator.
• Any treatment that suggests any of the aforementioned disease will be excluded.
• Depression with ongoing diagnosis and treatment, suicide idea or suicide behavior in the past 6 months.
• Contraindications or previously failure for receiving brain magnetic resonance imaging or PET scan.
• History of risk factors for torsades de pointes (a cardiac dysrhythmia associated with sudden death) or taking medications known to prolong the QT interval.
• Have an ECG obtained prior to the 18F-PM-PBB3 PET scan that in the opinion of the investigator is clinically significant regarding the subject's participation in the study.
• Pregnant, lactating or breastfeeding.
• Patients with severe liver disease (such as ALT \> 3x upper limit of normal).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital,Linkou

Taoyuan, Guishan Dist, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Amyloidosis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Kun-Ju MD Lin

CONTACT

03-3281200; kunjulin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 19, 2019
• Study Start: April 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: September 30, 2023
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

TW (1)