Quantitative Evaluation of [18F]T807 as a Potential PET Radioligand for Imaging Tau in Patients With Alzheimer's Disease

NCT02370524 | Completed Phase 1

• 1 other identifier: [18F]T807
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this exploratory imaging study is to further characterize \[18F\]T807, an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker indicative of neurodegeneration in conditions such as AD).

Conditions

Alzheimer's Disease (AD)

Outcome Measures

Primary Outcomes (1)

• Quantitative evaluation of [18F]T807 as a potential PET radioligand for imaging Tau in patients with clinically characterized tauopathies

  To further characterize \[18F\]T807, an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker indicative of neurodegeneration in conditions such as AD) and to assess the full quantitative evaluation of the PET outcome measures using \[18F\]T807 by pharmacokinetic (PK) modeling in order to derive a volume of distribution (VT) of \[18F\]T807 using arterial input function.

  1 year

Study Arms (1)

[18F]T807

EXPERIMENTAL

At the \[18F\]T807 PET imaging visit, subjects will be given a bolus injection of no more than 10 mCi (370 MBq) of \[18F\]T807

Drug: [18F]T807

Interventions

[18F]T807 DRUG

All enrolled subjects will undergo an \[18F\]T807 PET imaging visit. In addition, subjects with AD and aged volunteers will have one PET scan with Amyvid (florbetapir F 18 injection) as part of the screening activities to measure Aβ in the brain.

Also known as: Amyvid, [18F]florbetapir

[18F]T807

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all Subjects:
• Written informed consent or assent is obtained
• Female subjects/volunteers must 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 childbearing potential, must commit to the use of two effective contraception methods for the duration of the study.
• Male subjects/volunteers and their partners of childbearing potential must commit to the use of two effective methods of contraception, one of which should be a barrier method for male subjects.
• Prodromal and Mild Alzheimer's Disease Subjects
• Males and females aged between 50 and 90 years.
• Study partner has noticed a recent gradual decrease in the subject's memory (e.g., over the prior 12 months), which the subject may or may not be aware of.
• For prodromal subjects, abnormal memory function at screening or 4 weeks prior to screening based on the FCSRT-IR of:Free recall \<17, or Total recall \<40, or Free recall \<20 and total recall \<42.
• Individuals with mild AD must meet the criteria based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association and Diagnostic and Statistical Manual of Mental Disorders, Version 5, criteria. This evidence may be compiled during screening but must be fully documented in the subject's study file before the baseline visit.
• Have an MMSE (Folstein et al. 1975) score at screening \>20.
• Have an Amyvid (florbetapir F 18 injection) scan at screening that demonstrates amyloid binding based on qualitative analysis (visual read) that meets the criteria for AD.
• Modified Hachinski Ischemia Scale (Moroney et al. 1997) score of ≤ 4.

You may not qualify if:

• Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 4 weeks before the \[18F\]T807 imaging visit.
• Able to participate in all scheduled evaluations.
• The subject has an appropriate caregiver or community dwelling with a caregiver capable of accompanying the subject on all visits to the center as judged by the investigator.
• In the opinion of the investigator, the subject and caregiver will be compliant and have a high probability of completing the study.
• Healthy Volunteers
• Males and females aged between 20 and 90 years. Younger healthy controls will be aged 20-49 and older healthy controls will be aged 50-90.
• Healthy volunteers with no clinically relevant findings on physical examination at screening and upon reporting for the \[18F\]T807 imaging visit.
• No suspicion of cognitive impairment/early dementia from MMSE as judged by the investigator (MMSE\>28).
• No concomitant medications, over-the-counter, supplement, or any other agent intended to improve cognition or prevent cognitive decline
• A negative Amyvid (florbetapir F 18 injection) scan at screening based on qualitative analysis (visual read).
• For All subjects:
• Current or prior history of any alcohol or drug abuse.
• Severe systemic disease based on history and physical examination.
• Positive result on urine screen for illicit drugs.
• Laboratory tests with clinically significant abnormalities

Sponsors & Collaborators

• Molecular NeuroImaging: lead
• Institute for Neurodegenerative Disorders: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

Molecular NeuroImaging, LLC

New Haven, Connecticut, 06510, United States

Location

Related Publications (4)

• Fazekas F, Chawluk JB, Alavi A, Hurtig HI, Zimmerman RA. MR signal abnormalities at 1.5 T in Alzheimer's dementia and normal aging. AJR Am J Roentgenol. 1987 Aug;149(2):351-6. doi: 10.2214/ajr.149.2.351.

  PMID: 3496763 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Moroney JT, Bagiella E, Desmond DW, Hachinski VC, Molsa PK, Gustafson L, Brun A, Fischer P, Erkinjuntti T, Rosen W, Paik MC, Tatemichi TK. Meta-analysis of the Hachinski Ischemic Score in pathologically verified dementias. Neurology. 1997 Oct;49(4):1096-105. doi: 10.1212/wnl.49.4.1096.

  PMID: 9339696 BACKGROUND

• Barret O, Alagille D, Sanabria S, Comley RA, Weimer RM, Borroni E, Mintun M, Seneca N, Papin C, Morley T, Marek K, Seibyl JP, Tamagnan GD, Jennings D. Kinetic Modeling of the Tau PET Tracer 18F-AV-1451 in Human Healthy Volunteers and Alzheimer Disease Subjects. J Nucl Med. 2017 Jul;58(7):1124-1131. doi: 10.2967/jnumed.116.182881. Epub 2016 Dec 1.

  PMID: 27908967 DERIVED

Related Links

• Molecular NeuroImaging
• Institute for Neurodenerative Disorders

MeSH Terms

Conditions

Alzheimer Disease

Interventions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Danna Jennings, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 25, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 8, 2017

Record last verified: 2017-03

Locations

US (1)