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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)

Primary Purpose

Alzheimer's Disease

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

[18F]AV-45 PET amyloid binding imaging

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring [18F]AV-45 PET amyloid binding imaging, Alzheimer's disease, mild cognitive impartment,

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]AV-45 PET amyloid binding imaging

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01238458

First Posted

October 21, 2010

Last Updated

September 27, 2012

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01238458

Brief 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

Acronym

[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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Unknown status

Study Start Date

November 2009 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

[18F]AV-45 PET amyloid binding imaging

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

[18F]AV-45 PET amyloid binding imaging

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

one year

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

two year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. 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.

12. IPD Sharing Statement

Learn more about this trial

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

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