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Beta-Amyloid Imaging With [18F]NAV4694 Positron Emission Tomography (PET) in Predicting Progression to Alzheimer's Disease (AD) in Subjects With Mild Cognitive Impairment (MCI)

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Trial Conditions
  • Mild Cognitive Impairment
What is the purpose of this trial?

To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with mild cognitive impairment (MCI) who progress to Alzheimer's disease (AD) from those who do not.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
65 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Subject has signed informed consent to participate in the study and continues to give
willing consent for participation

- Age ≥ 65 years with a diagnosis of MCI

- Educational level of at least 6 years

- Female subjects will not be of child-bearing potential (> 1 year post-menopausal or
surgically sterile)

- Availability of a "study partner" who can assist in completing rating scales for the
duration of the study

- Cognitive complaints reported by the subject and confirmed by the "study partner"

- Clinical Dementia Rating (CDR) global score = 0.5

- Mini-mental state examination (MMSE) score of 24-28

- Diagnostic and Statistical Manual of Mental Disorders, Version 4, Text Revised
(DSM-IV-TR) criteria of dementia not fulfilled

Exclusion Criteria:

- Has been previously enrolled in this study and received the investigational product

- Has participated in a clinical study involving an investigational pharmaceutical
product within 30 days prior to screening

- Has received anti-amyloid immunotherapy

- Has exceeded yearly radioactive dose of 30 mSv

- Has a known allergy to the study drug or any of its constituents

- Has a history of alcohol abuse or alcohol dependency in the 3 years prior to study
entry, or is an alcoholic or drug addict, as determined by the investigator

- Has ongoing clinically significant (as judged by the investigator), metabolic or any
other disease that could currently cause impaired memory (e.g., untreated thyroid
disease, vitamin or other nutritional deficiencies, chronic kidney, or liver disease)

- Regular use of psychoactive medications that could affect cognition (e.g.,
benzodiazepines, sedatives, antipsychotics)

- Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48
hours prior to, or a therapeutic radiopharmaceutical (e.g., 131I) within 10 days
prior to, or any radiopharmaceutical administration within 10 radioactive half-lives
prior to the administration of the investigational product or for whom administration
of such substances is planned within 7 days after investigational product
administration

- History of major recurrent depressive disorder (per DSM-IV-TR) within the last 5
years prior to screening

- Has a brain tumor or other intracranial lesion, a disturbance of cerebral spinal
fluid circulation (e.g., normal pressure hydrocephalus), and/or a significant history
of head trauma or brain surgery

- Has signs of major cerebrovascular disease, as verified by medical history and/or
brain MRI

- Is scheduled for surgery and/or another invasive procedure within the 7 days
following investigational product administration

- Has any contraindication to MRI examination, e.g., metal implants, phobia, or cannot
undergo an MRI for other reasons such as the inability to lie flat

Gender: Both
Steward Physician(s)
  • Cornelia Reininger, MD, PhD
Trial Interventions
Drug
  • [18F]NAV4694
Physician Researcher

Investigator Name:

  • Cornelia Reininger, MD, PhD

Other Information

Sponsor: Navidea Biopharmaceuticals
Phase: Phase 2
Trial ID: NCT01812213
Volunteers:  Not Accepting Healthy Volunteers

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