Phase II Study for Amyloid Binding Imaging Study of [18F]AV-45 in Patients With Mild Cognitive Impairment, Alzheimer's Disease and Healthy Volunteers ([18F]AV-45)

This study will recruit a total of 150 evaluable subjects (30 cognitively normal volunteers, and 60 MCI(Mild cognitive impairment), and 60 AD(Alzheimer's disease), respectively) Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.

Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

This study is expected to be completed in a period of 3 years.

Study Overview

• Status: Unknown
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: [18F]AV-45 PET amyloid binding imaging

Detailed Description

The primary objective of this protocol is to address the feasibility of clinical utilization of [18F]AV-45 in various neurodegenerative diseases. Specifically, we will expand the database of [18F]AV-45 PET imaging in Alzheimer's disease and MCI patients to refine the definition of a positive scan in patient with AD and MCI as compared to healthy control. Secondary, we will expand the safety database of [18F]AV-45 PET imaging. In addition, the image characteristics and prevalence of Aß positivity will be evaluated in different subsets of MCI and AD patients.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Both genders ≥ 50 years old.
• Written and dated informed consent by self or by legal representative, to be obtained before any of the study procedures.
• 30 cognitively normal volunteers with no evidence of significant cognitive impairment by history and psychometrictesting (MMSE > 24).
• 60 subjects with a diagnosis of AD according to the NINCDS-ADRDA criteria.
• 60 subjects with a diagnosis of MCI

Exclusion Criteria:

1. Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding.
2. Modified Hachinski ischemic score of >4 or those who meet the NINDS-AIREN criteria for vascular dementia.

3. Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.

   • Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances, especially thyroid disease;

   • Current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following:

     • cardiac surgery or myocardial infarction within the last 6 months;
     • unstable angina
     • coronary artery disease that required a change in medication within the last 3 months
     • decompensated congestive heart failure
     • significant cardiac arrhythmia or conduction disturbance, particularly those resulting in atrial or ventricular fibrillation, or causing syncope, near syncope, or other alterations in mental status
     • severe mitral or aortic valvular disease
     • uncontrolled high blood pressure
     • congenital heart disease
     • clinically significant abnormal result on ECG, including but not limited to QTc>450 msec iii. Clinically significant infectious disease, including AIDS or HIV infection or active hepatitis B, active hepatitis C, HIV-1, or HIV-2
4. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
5. Patients who have the evidence of neurodegenerative disorders other than AD, cognitive impairment resulting from trauma or brain damage, brain infarction, clinically significant psychiatric disease, epilepsy, are excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: [18F]AV-45 PET amyloid binding imaging

Drug: [18F]AV-45 PET amyloid binding imaging; This study will recruit a total of 150 evaluable subjects (30 cognitively normal volunteers, and 60 MCI, and 60 AD, respectively) Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To expand the safety database of [18F]AV-45 PET imaging	To expand the database of [18F]AV-45 PET imaging in Alzheimer's disease and MCI patients to refine the definition of a positive scan in patient with AD and MCI as compared to healthy control.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To expand the safety database of [18F]AV-45 PET imaging	To expand the safety database of [18F]AV-45 PET imaging Safety variables include adverse event count, lab parameters, vital signs, and ECG. Comparison will be generally made to baseline, as appropriate. To understand prevalence of Aß positivity in patients with MCI and AD. Images will be visually examined by a trained radiologist or nuclear medicine physician who is blinded to the subject diagnosis and will be reported as either Aβ positive (AD-like) or Aβ negative (not AD-like). The prevalence of Aß positivity in patients with MCI and AD will be recorded for comparison.	two year

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ANTICIPATED): June 1, 2013

Study Registration Dates

• First Submitted: October 21, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (ESTIMATE): November 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 28, 2012
• Last Update Submitted That Met QC Criteria: September 27, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Alzheimer's disease; [18F]AV-45 PET amyloid binding imaging; mild cognitive impartment,
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 98-1852A