Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Tauopathies

NCT02531360 | Completed Early Phase 1

• 1 other identifier: MNI-815
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this imaging trial is to characterize \[18F\]MNI-815, a PET radioligand for imaging Tau.

Conditions

Alzheimer's Disease (AD); Progressive Supranuclear Palsy (PSP); Cortical Basal Syndrome (CBS); Frontal Temporal Dementia (FTD)

Outcome Measures

Primary Outcomes (1)

• Brain uptake of [18F]MNI-815

  The PET imaging outcome measure to evaluate tau burden will be the standardized uptake value (SUV), which will be calculated for the areas of interest by using the established methods for normalizing to subject weight and injected dose.

  18 months

Study Arms (1)

[18F]MNI-815 (MNI-815)

EXPERIMENTAL

At the \[18F\]MNI-815 PET imaging visit, subjects will be injected with no more than 10mCi of \[18F\]MNI-815

Drug: [18F]MNI-815 (MNI-815)

Interventions

[18F]MNI-815 (MNI-815) DRUG

All enrolled subjects will undergo an \[18F\]MNI-815 PET imaging visit. As a part of the screening visit, subjects will undergo \[18F\]florbetaben (FBB) PET imaging to determine if they have significant amyloid deposition.

Also known as: [18F]MNI-815, FBB, [18F]Florbetaben

[18F]MNI-815 (MNI-815)

Eligibility Criteria

• Age: 50 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 must be obtained before any assessment is performed.
• Female subjects 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 child-bearing potential, must commit to use of 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
• Willing and able to cooperate with study procedures
• Healthy Control subjects:
• Males and females aged between 50 - 70 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F\]MNI-815 imaging visit.
• No cognitive impairment from neuropsychological battery as judged by the investigator
• Have a CDR score=0
• Has FBB PET imaging demonstrating no evidence for significant amyloid binding based on qualitative (visual read) and quantitative analysis.
• Modified Hachinski Ischemia Scale score of ≤ 4.
• Prodromal or Moderate Alzheimer's Disease subjects:
• Males and females aged between 50 - 90 years.
• Have prodromal or moderate Alzheimer's disease, based on the NINCDS/ADRDA and DSM-IV criteria.
• Have a CDR score of 0.5 for prodromal AD subjects and CDR \> 1.0 for moderate AD subject at screening.

You may not qualify if:

• Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 1 month before the \[18F\]MNI-815 imaging visit.
• The subject has an appropriate caregiver capable of accompanying subject on all visits.
• Signed and dated written informed consent obtained from the subject and, when applicable, the subject's legally authorized representative or caregiver.
• Frontotemporal Dementia subjects:
• Has a clinical diagnosis of FTD based on consensus for clinical diagnosis of frontotemporal dementia criteria (Neary, et al 1998)
• Has a FBB PET imaging demonstrating no evidence of significant amyloid binding based on qualitative (visual read) and quantitative analysis.
• Medications taken for symptomatic treatment of cognitive dysfunction must be maintained on a stable dosage regimen for at least 1 month before the screening visit.
• The subject has an appropriate caregiver capable of accompanying subject on all visits to the center.
• Signed and dated written informed consent obtained from the subject and, when applicable, the subject's legally authorized representative or caregiver.
• Modified Hachinski Ischemia Scale score of ≤ 4.
• Progressive Supranuclear Palsy subjects:
• Has a clinical diagnosis of PSP based the NINDS and Society for PSP criteria (Litvan, et al 1996)
• Has FBB PET imaging demonstrating no evidence of significant amyloid binding based on qualitative (visual read) and quantitative analysis.
• Medications taken for treatment of PSP symptoms must be maintained on a stable dosage regimen for at least 1 month before the screening visit.
• The subject has an appropriate caregiver capable of accompanying subject on all visits to the center.

Sponsors & Collaborators

• Molecular NeuroImaging: lead
• Life Molecular Imaging SA: collaborator

Study Sites (1)

Molecular NeuroImaging, LLC

New Haven, Connecticut, 06510, United States

Location

Related Publications (3)

• Neary D, Snowden JS, Gustafson L, Passant U, Stuss D, Black S, Freedman M, Kertesz A, Robert PH, Albert M, Boone K, Miller BL, Cummings J, Benson DF. Frontotemporal lobar degeneration: a consensus on clinical diagnostic criteria. Neurology. 1998 Dec;51(6):1546-54. doi: 10.1212/wnl.51.6.1546.

  PMID: 9855500 BACKGROUND

• Litvan I, Agid Y, Calne D, Campbell G, Dubois B, Duvoisin RC, Goetz CG, Golbe LI, Grafman J, Growdon JH, Hallett M, Jankovic J, Quinn NP, Tolosa E, Zee DS. Clinical research criteria for the diagnosis of progressive supranuclear palsy (Steele-Richardson-Olszewski syndrome): report of the NINDS-SPSP international workshop. Neurology. 1996 Jul;47(1):1-9. doi: 10.1212/wnl.47.1.1.

  PMID: 8710059 BACKGROUND

• Armstrong MJ, Litvan I, Lang AE, Bak TH, Bhatia KP, Borroni B, Boxer AL, Dickson DW, Grossman M, Hallett M, Josephs KA, Kertesz A, Lee SE, Miller BL, Reich SG, Riley DE, Tolosa E, Troster AI, Vidailhet M, Weiner WJ. Criteria for the diagnosis of corticobasal degeneration. Neurology. 2013 Jan 29;80(5):496-503. doi: 10.1212/WNL.0b013e31827f0fd1.

  PMID: 23359374 BACKGROUND

Related Links

• Molecular NeuroImaging
• Institute for Neurodegenerative Disorders

MeSH Terms

Conditions

Alzheimer Disease; Supranuclear Palsy, Progressive

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Basal Ganglia Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Danna Jennings, MD

  Molecular NeuroImaging, LLC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: August 24, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

US (1)