Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain

NCT03080051 | Completed Early Phase 1

• 1 other identifier: [18F]MNI-952
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this imaging trial is to evaluate \[18F\]MNI-952 (also known as \[18F\]UCB-K), a tau targeted PET radioligand.

Conditions

Progressive Supranuclear Palsy; Alzheimer Disease; Healthy Volunteers

Keywords

PSP; AD; HV

Outcome Measures

Primary Outcomes (1)

• Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-952 binding/uptake and expressed in SUV by using established methods for normalization for 2 PSP, 2 AD, and 2 HV subjects.

  Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-952.

  1 year

Study Arms (1)

[18F]MNI-952

EXPERIMENTAL

To evaluate \[18F\]MNI-952 (also known as \[18F\]UCB-K), a tau targeted PET radioligand.

Drug: [18F]MNI-952; Drug: [18F]Florbetapir

Interventions

[18F]MNI-952 DRUG

Subjects will undergo PET imaging using \[18F\]MNI-952, a PET radioligand for imaging tau.

Also known as: [18F]UCB-K

[18F]MNI-952

[18F]Florbetapir DRUG

Subjects with Alzheimer's disease will receive a \[18F\]florbetapir scan to compare distribution of tau in the brain compared to that of \[18F\]MNI-952.

[18F]MNI-952

Eligibility Criteria

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

You may qualify if:

• 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 study duration and for 90 days following participation.
• Willing and able to cooperate with study procedures
• Males and females aged \<55 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F\]MNI-952 imaging visit.
• No neurologic impairment as judged by the investigator
• No family history of Alzheimer's disease or neurological disease associated with dementia
• Have a CDR score=0
• Males and females aged between 50 and 90 years.
• Have probable Alzheimer's disease, based on the NINCDS/ADRDA and DSM-IV criteria.
• Have a CDR score of 0.5 or greater at screening.
• Have an MMSE score ≤ 28.
• Have a screening \[18F\]florbetapir PET imaging demonstrating amyloid binding based on qualitative (visual read)

You may not qualify if:

• Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 30 days before the screening visit
• The subject has an appropriate caregiver capable of accompanying subject, if necessary.
• Signed and dated written informed consent obtained from the subject and/or the subject's legally authorized representative or caregiver (if applicable).
• Males and females aged 50 to 90 years.
• Has a clinical diagnosis of PSP based on the NINDS and Society for PSP criteria (Litvan, et al 1996).
• Have screening DaTSCAN SPECT imaging demonstrating evidence of dopamine transporter deficit based on qualitative (visual) read.
• Medications taken for symptomatic treatment of PSP must be maintained on a stable dosage regimen for at least 30 days before screening visit.
• The subject has an appropriate caregiver capable of accompanying subject, if necessary.
• Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
• Current or prior history of any alcohol or drug abuse.
• Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
• Subject has received an investigational drug or device within 30 days of screening
• Prior participation in other research protocols or clinical care in the last year such that radiation exposure exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines.
• Pregnancy, lactating or breastfeeding.
• Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.

Sponsors & Collaborators

• Molecular NeuroImaging: lead

Study Sites (1)

Molecular NeuroImaging, LLC

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• 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

Related Links

• Related Info

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

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

Study Officials

• Jennifer Madonia, PA-C

  Molecular NeuroImaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: March 15, 2017
• Study Start: August 1, 2016
• Primary Completion: March 6, 2017
• Study Completion: March 6, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (1)