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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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Tzu-Chen Yen, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01238458
First received: October 21, 2010
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: [18F]AV-45 PET amyloid binding imaging
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • To expand the safety database of [18F]AV-45 PET imaging [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: two year ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 150
Study Start Date: November 2009
Estimated Study Completion Date: June 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Tzu-Chen Yen, Nuclear Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01238458     History of Changes
Other Study ID Numbers: 98-1852A
Study First Received: October 21, 2010
Last Updated: September 27, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
[18F]AV-45 PET amyloid binding imaging
Alzheimer's disease
mild cognitive impartment,

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 24, 2014