Safety and Efficacy of Positron Emission Tomography (PET) Imaging With MNI-558

NCT01217021 | Completed Early Phase 1

• 1 other identifier: MNI-558-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This research will look at how the brain may change in people with Alzheimer disease (AD). The purpose of this research is to find out whether changes in the brain in people with Alzheimer disease can be detected using a brain imaging test. Most people with Alzheimer disease have changes in the brain that result in deposits of a protein called beta-amyloid. In this study, the investigators will be using a radioactive drug, \[18F\]MNI-558 that binds to beta-amyloid. This drug is experimental and has not been approved by the FDA. Brain imaging using PET (positron emission tomography) will be done to see if the investigators can evaluate the areas of beta-amyloid in the subjects with Alzheimer disease. The investigators will compare these scans with those done in healthy normal volunteers. PET is a brain-scanning test used in medicine and scientific research to see how the brain is working. The PET imaging test used in this study is not being done for diagnostic purposes.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy safety of MNI-558 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer disease (AD) compared to healthy volunteers (HV)

  To determine diagnostic efficacy of the MNI-558 PET scans in differentiating between patients with probable AD and HVs on the basis of neocortical tracer binding pattern, the PET scans will be visually assessed by a nuclear physician experienced in the field of neuro-imaging. Safety will be assessed from the rates of adverse events (AEs), changes in vital signs, changes in ECG parameters, changes in physical examination findings, changes in clinical laboratory findings, changes in injection site monitoring at pre-specified time points before and after IMP administration

  1 year

Secondary Outcomes (3)

• To assess the dynamic uptake of MNI-558, a potential imaging biomarker for B-amyloid burden in brain, using positron emission tomography (PET) in similarly aged Alzheimer (AD) subjects and healthy volunteers (HV

  1 year

• To determine pharmacokinetics pattern of MNI-558 in venous plasma of healthy and AD subjects.

  1 year

• To determine metabolite pattern of MNI-558 in venous plasma of healthy and AD subjects.

  1 year

Study Arms (1)

Assess [18F] MNI-558 and PET imaging

EXPERIMENTAL

Drug: [18F] MNI-558

Interventions

[18F] MNI-558 DRUG

Subjects will be injected with 5mCi, not to exceed \>10% of 5mCI, of \[18F\]MNI-558, followed by PET imaging.

Assess [18F] MNI-558 and PET imaging

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• is a man or woman and is ≥ 55 of age, whereby females must be without childbearing potential (confirmed by either: age ≥ 60; or history of surgical sterilization or of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)
• has at least 6 years of education
• is able to provide informed consent or assent, and exhibits adequate visual, auditory and communication capabilities to enable compliance with study procedures. This includes performing the psychometric testing and being able to lie down flat in the PET scanner
• possesses a general health that permits adequate compliance with all study procedures as ascertained by a detailed review of the medical history, laboratory and physical examination findings, which must be performed within 28 days prior to administration of IMP
• the subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study in the opinion of the investigator
• informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients)

You may not qualify if:

• has any contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan
• is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
• is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
• is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable, e.g. patients / volunteers within 14 days of myocardial infarction or stroke, unstable patients / volunteers with previous surgery (within 7 days), patients with advanced heart insufficiency (NYHA stage IV), or with acute renal failure
• has a history of exposure to any radiation \>15 mSv/year (e.g. occupational or radiation therapy)
• is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
• has received anti-amyloid drug therapy.
• has received any contrast material (X-ray, MRI) or radiopharmaceuticals within 48 hours prior to the application of the IMP or for whom application of such a substance is planned for the 24 hours following IMP administration
• has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical within 10 radioactive half-lives prior to IMP administration
• has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
• has an inflammatory or infectious CNS disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeld-Jacob disease
• has a history, physical, laboratory or imaging findings indicative of a significant neurological or psychiatric illness (for patients - other than AD)
• has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
• has a history of alcohol or drug abuse
• has history of severe persistent depression

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead
• Molecular NeuroImaging: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

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: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 8, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

US (1)