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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 | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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•Chang Gung Memorial Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+6 more criteria

Key Dates

Start Date

November 1, 2009

Primary Completion Date

November 1, 2011

Completion Date

June 1, 2013

Last Updated

September 28, 2012

Enrollment

150

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

[18F]AV-45 PET amyloid binding imaging

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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