Beta-Amyloid Imaging With [18F]NAV4694 PET in Predicting Progression to AD in Subjects MCI (NAV4-04)

Navidea Biopharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Mild Cognitive Impairment

Treatments

Drug: [18F]NAV4694

Study type

Interventional

Funder types

Industry

Identifiers

NCT01812213

NAV4-04

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

55 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has signed informed consent to participate in the study and continues to give willing consent for participation
Age ≥ 55 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 24-30
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 received an investigational product within 30 days prior to screening
Has received disease-modifying therapy that could have changed amyloid brain deposition
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)
Memory impairment that can be attributed to a disease or condition other than an early phase neurodegenerative syndrome
Has a parkinsonian movement disorder
Use of psychoactive medications that would affect the subject's ability to reliably perform neurocognitive testing or create uncertainty in distinguishing between the effects of the psychoactive medication and the subject's underlying cognitive impairment (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