Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain

NCT ID: NCT03058965

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-29
• Study Completion Date: 2018-05-11

Brief Summary

The overall goal of this imaging trial is to evaluate [18F]MNI-958, a tau targeted PET radioligand, in individuals with Alzheimer's disease (AD), Progressive Supranuclear Palsy (PSP), and healthy volunteers (HV).

Conditions

Alzheimer Disease; Healthy Volunteers; Progressive Supranuclear Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

[18F]MNI-958

To evaluate \[18F\]MNI-958, a tau targeted PET radioligand.

Group Type: EXPERIMENTAL

[18F]MNI-958

Intervention Type: DRUG

Subjects will undergo PET imaging using \[18F\]MNI-958, a PET radioligand for imaging tau.

[18F]Florbetapir

Intervention Type: 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-958.

DaTscan

Intervention Type: DRUG

DaTscan SPECT imaging will be completed in those PSP subjects who have not previously had DATScan imaging as part of the screening procedures.

Interventions

[18F]MNI-958

Subjects will undergo PET imaging using \[18F\]MNI-958, a PET radioligand for imaging tau.

Intervention Type: DRUG

[18F]Florbetapir

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-958.

Intervention Type: DRUG

DaTscan

DaTscan SPECT imaging will be completed in those PSP subjects who have not previously had DATScan imaging as part of the screening procedures.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 and able to cooperate with study procedures

• Males and females aged ≥50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the [18F]MNI-958 imaging visit.
• No cognitive impairment from neuropsychological battery as judged by the investigator
• Have screening [18F]florbetapir PET imaging demonstrating no significant amyloid binding based on qualitative analysis (visual read).
• No family history of Alzheimer's disease or neurological disease associated with dementia
• Have a CDR score=0

• Males and females aged 50 to 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 screening or prior (in the last 12 months) [18F]florbetapir PET imaging demonstrating amyloid binding based on qualitative (visual read)

• 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 or prior DaTscan SPECT imaging demonstrating evidence of dopamine transporter deficit based on visual read.
• A brain MRI that supports a diagnosis of PSP, with no other evidence of significant neurologic pathology
• Medications taken for symptomatic treatment of PSP must be maintained on a stable dosage regimen for at least 30 days before screening visit.
• Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
• The subject has an appropriate caregiver capable of accompanying subject, if necessary.

Exclusion Criteria

• Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 30 days before the screening visit.
• Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
• The subject has an appropriate caregiver capable of accompanying subject, if necessary.

• 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 in addition to the radiation exposure expected from participation in this clinical study, 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.
• Unsuitable veins for repeated venipuncture.
• Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.

• Has received treatment that targeted amyloid-β or tau within the last 3 months.

• Ongoing treatment with methylphenidate, bupropion, modafinil, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Molecular NeuroImaging

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Molecular NeuroImaging, LLC

New Haven, Connecticut, United States

Countries

United States

Related Links

https://mnimaging.com/

Related Info

Other Identifiers

[18F]MNI-958

Identifier Type: -

Identifier Source: org_study_id