Clinical trial NCT01812213: Beta-Amyloid Imaging With [18F]NAV4694 PET in Predicting Progression to AD in Subjects MCI
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Lead sponsor: Navidea Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-03-18
Enrollment: 76
Sex: ALL
Minimum age (years): 55
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease
timeFrame: 3 Years
Secondary outcomes:
measure: Incidence of [18F]NAV4694 PET Positive Scans at 18 Months Compared to Baseline
timeFrame: 18 months
measure: Change in Neuro-cognitive Test Battery Scores at 6 Months Compared to Baseline
timeFrame: 6 months
measure: Change in Neuro-cognitive Test Battery Scores at 12 Months Compared to Baseline
timeFrame: 12 months
measure: Change in Neuro-cognitive Test Battery Scores at 18 Months Compared to Baseline
timeFrame: 18 months
measure: Change in Neuro-cognitive Test Battery Scores at 24 Months Compared to Baseline
timeFrame: 24 months
measure: Change in Neuro-cognitive Test Battery Scores at 30 Months Compared to Baseline
timeFrame: 30 months
measure: Change in Neuro-cognitive Test Battery Scores at 36 Months Compared to Baseline
timeFrame: 36 months
measure: Change in SUVR Scores at 18 Months Compared to Baseline
timeFrame: 36 months
measure: Incidence of Adverse Events Post Baseline
timeFrame: 3 Years
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Miami Beach
country: United States
facility: Mt. Sinai Wien Center for Alzheimer's Disease
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Quincy
country: United States
facility: Qunicy Medical Center, Alzheimer's Disease Center
state: Massachusetts
city: Albany
country: United States
facility: Neurological Associates of Albany
state: New York
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Navidea Biopharmaceuticals Inc.
name: Cornelia Reininger, MD, PhD
role: STUDY_DIRECTOR
References: