Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss

NCT03587649 | Completed Phase 1 FDA Drug

• 1 other identifier: [18F]MNI-1126
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this protocol is to examine \[18F\]MNI-1126 as a tool to assess synaptic density loss.

Conditions

Alzheimer Disease; Parkinson Disease; Healthy Volunteers

Keywords

AD; PD; HV

Outcome Measures

Primary Outcomes (1)

• Regions in the VOI template will be used to quantify the regional tracer uptake and used for comparison of potential uptake differences across the different groups.

  Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-1126.

  1 year

Study Arms (1)

[18F]MNI-1126

EXPERIMENTAL

To measure the dynamic uptake and washout of \[18F\]MNI-1126 in the brain using positron emission tomography (PET) in subjects with AD, PD, and healthy volunteers.

Drug: [18F]MNI-1126

Interventions

[18F]MNI-1126 DRUG

Florbetapir PET imaging will be completed in all healthy volunteers and AD subjects as part of the screening procedures. DaTscan SPECT imaging will be completed in those PDsubjects who have not previously had DaTscan imaging as part of the screening procedures.

[18F]MNI-1126

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 (i.e. 12 consecutive months with no menses without an alternative medical cause) or, if they are of child-bearing potential, must commit to use two methods of contraception, one of which is a barrier 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.
• For females, non-child bearing potential or negative urine pregnancy test on day of \[18F\]MNI-1126 injection.
• Are males or females ≥ 30 years of age.
• Must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.
• Have Hoehn and Yahr stage ≤3.
• Have a MMSE score ≥ 22.
• PD subjects may be treated with PD symptomatic therapy on a stable dose of medications for a period of at least 30 days prior to the \[18F\]MNI-1126 PET imaging visit.
• Have screening or prior DaTscan SPECT imaging demonstrating evidence of dopamine transporter deficit based on visual read.
• Males and females aged ≥50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F\]MNI-1126 imaging visit.
• No cognitive impairment from neuropsychological battery as judged by the investigator.
• Have screening or prior ( in the last 12 months ) amyloid PET imaging demonstrating no significant 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 screening visit.
• Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
• 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.
• Are claustrophobic or otherwise unable to tolerate the imaging procedure
• Has received treatment that targeted Aβ or tau within the last 3 months.
• Ongoing treatment with methylphenidate, modafinil, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative for subjects requiring DaTscan imaging.
• Subjects may take stable doses of bupropion, however this medication must be held for at least 12 hours prior to DaTscan imaging.
• Subject has known hypersensitivity to iodine or potassium iodide (KI) in the opinion of the Investigator.

Sponsors & Collaborators

• Invicro: lead

Study Sites (1)

Invicro

New Haven, Connecticut, 06510, United States

Location

Related Links

• Invicro home page

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Officials

• David Russell, M.D., Ph. D

  Invicro

  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: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 16, 2018
• Study Start: May 7, 2018
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

US (1)