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

Alzheimer's Disease Clinical Trial

— [18F]AV-45  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01238458
• Other study ID #: 98-1852A
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: October 21, 2010
• Last updated: September 27, 2012
• Start date: November 2009
• Est. completion date: June 2013

Study information

• Verified date: September 2012
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: June 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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 Aß positive (AD-like) or Aß negative (not AD-like). The prevalence of Aß positivity in patients with MCI and AD will be recorded for comparison.	two year	Yes