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

NCT01238458 | Unknown Phase 2 DMC

• 1 other identifier: 98-1852A
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

[18F]AV-45 PET amyloid binding imaging; Alzheimer's disease; mild cognitive impartment,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To expand the safety database of [18F]AV-45 PET imaging

  two year

Study Arms (1)

[18F]AV-45 PET amyloid binding imaging

EXPERIMENTAL

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

Interventions

[18F]AV-45 PET amyloid binding imaging DRUG

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.

[18F]AV-45 PET amyloid binding imaging

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• cognitively normal volunteers with no evidence of significant cognitive impairment by history and psychometrictesting (MMSE \> 24).
• subjects with a diagnosis of AD according to the NINCDS-ADRDA criteria.
• subjects with a diagnosis of MCI

You may not qualify if:

• 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.
• Modified Hachinski ischemic score of \>4 or those who meet the NINDS-AIREN criteria for vascular dementia.
• 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
• History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nuclear Medicine

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: November 10, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: June 1, 2013
• Last Updated: September 28, 2012

Record last verified: 2012-09