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Establish Taiwan Alzheimer's Disease Neuroimaging Initiative - a Three-year Pilot Study (Alzheimer's)

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
F18-AV45
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Enrolled subjects will be between 55-90 (inclusive) years of age, at least 6 years of formal education, and have a study partner able to provide an independent evaluation of functioning. All subjects must be willing and able to undergo all test procedures including neuroimaging and agree to longitudinal follow up. Specific psychoactive medications will be excluded. General inclusion/exclusion criteria are as follows:

  1. Normal subjects: MMSE scores between 24-30 (inclusive), a CDR of 0, non-depressed, non-MCI, and nondemented, education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years:≥9; 6-15 years: ≥5).
  2. EMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: 9-11; 6-15 years: 5-9), a CDR sum of box of 0.5 (0.5 only in memory subdomain), absence of significant levels of impairment in other cognitive domains, essentially preserved activities of daily living, and an absence of dementia.
  3. LMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: ≤8; 6-15 years: ≤4), a CDR of 0.5 with a mandatory requirement of the memory box score being 0.5 or greater, essentially preserved activities of daily living, and an absence of dementia.
  4. Mild AD: MMSE scores between 20-26 (inclusive), CDR of 0.5 or 1.0, and meets NINCDS/ADRDA criteria for probable AD, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: ≤8; 6-15 years: ≤4)

Exclusion criteria:

Subjects taking antidepressant medications with anticholinergic properties will be excluded, and the regular use of narcotic agents have to be limited to < 2 doses per week within 4 weeks of screening. Neuroleptic medications and other drugs with anticholinergic properties, anti-parkinsonian medications are not allowed within 4 weeks of screening. Diuretic drugs should not be started or need to be discontinued 4 weeks prior to screening. Cholinesterase inhibitors and memantine are permitted if the doses are stable for 4 weeks prior to screening for subjects with MCI and AD. Estrogen and estrogen-like compounds and vitamin E are allowed if the dose have been stable for 4 weeks prior to screening. Participants are required to report any medication changes to the site investigators once they are enrolled in the study.

Sites / Locations

  • Tzu-Chen-YenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

F18-AV45

Arm Description

Outcomes

Primary Outcome Measures

Rate of conversion from NC, EMCI, LMCI to AD.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2012
Last Updated
June 17, 2012
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01624389
Brief Title
Establish Taiwan Alzheimer's Disease Neuroimaging Initiative - a Three-year Pilot Study
Acronym
Alzheimer's
Official Title
Establish Taiwan Alzheimer's Disease Neuroimaging Initiative - a Three-year Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Alzheimer's disease (AD) may be one of the most pressing problems facing all countries around the world as the population ages.AD is a slowly evolving process that likes begins years to decades before the clinical symptoms area manifest. However, as one would like to identify the disease process at an earlier point in the clinical continuum, the precision of the diagnosis is reduced. Therefore, the challenge is to try to identify the process at the pre-dementia stage and enhance the specificity of the clinical diagnosis through the use of imaging and other biomarkers. Mild cognitive impairment (MCI) represents an attempt to characterize subjects at an early clinical phase of AD and subjects with MCI have been a target for prevention trials. There are two pathological landmarks, in terms of extra-cellular senile plaques and intracellular neurofibrillary tangles. Although present symptomatic treatments provide some benefit to patients with AD, they are not the solution for AD. Up to date, there are still no therapies can alter the underlying nature of the AD process. Therefore, the earlier the intervention takes place, presumably, the greater the protection against further neuronal damage will be appreciated.The Alzheimer's Disease Neuroimaging Initiate (ADNI) is a consortium of universities and medical centers in the United States and Canada established to develop standardized imaging techniques and biomarkers procedures in normal subjects, subjects with MCI and subjects with mild AD. ADNI has been a groundbreaking project, establishing pre-competitive collaboration and real-time data sharing among academia and industry investigators to clarify the relationships among demographic, genetic, clinical, cognitive, neuroimaging and biochemical measures throughout the course of AD neurobiology, in order to facilitate the development of effective therapeutics.This project has exceeded expectations, providing insights into disease mechanisms as well as hugely valuable advances, based primarily on the use of standardized biomarkers, to drug development programs. A number of the leading disease-modifying drug development programs are now employing ADNI methodology toward more efficient trial design, particularly in the critically important early (pre-dementia) AD population
Detailed Description
Eligibility: Normal subjects: MMSE scores between 24-30 (inclusive), a CDR of 0, non-depressed, non-MCI, and nondemented, education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years:≥9; 6-15 years: ≥5). EMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: 9-11; 6-15 years: 5-9), a CDR sum of box of 0.5 (0.5 only in memory subdomain), absence of significant levels of impairment in other cognitive domains, essentially preserved activities of daily living, and an absence of dementia. LMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: ≤8; 6-15 years: ≤4), a CDR of 0.5 with a mandatory requirement of the memory box score being 0.5 or greater, essentially preserved activities of daily living, and an absence of dementia.

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
F18-AV45
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
F18-AV45
Intervention Description
This study will recruit a total of 200 evaluable subjects (50 cognitively normal volunteers, 100 MCI, and 50 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
Rate of conversion from NC, EMCI, LMCI to AD.
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Enrolled subjects will be between 55-90 (inclusive) years of age, at least 6 years of formal education, and have a study partner able to provide an independent evaluation of functioning. All subjects must be willing and able to undergo all test procedures including neuroimaging and agree to longitudinal follow up. Specific psychoactive medications will be excluded. General inclusion/exclusion criteria are as follows: Normal subjects: MMSE scores between 24-30 (inclusive), a CDR of 0, non-depressed, non-MCI, and nondemented, education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years:≥9; 6-15 years: ≥5). EMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: 9-11; 6-15 years: 5-9), a CDR sum of box of 0.5 (0.5 only in memory subdomain), absence of significant levels of impairment in other cognitive domains, essentially preserved activities of daily living, and an absence of dementia. LMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: ≤8; 6-15 years: ≤4), a CDR of 0.5 with a mandatory requirement of the memory box score being 0.5 or greater, essentially preserved activities of daily living, and an absence of dementia. Mild AD: MMSE scores between 20-26 (inclusive), CDR of 0.5 or 1.0, and meets NINCDS/ADRDA criteria for probable AD, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: ≤8; 6-15 years: ≤4) Exclusion criteria: Subjects taking antidepressant medications with anticholinergic properties will be excluded, and the regular use of narcotic agents have to be limited to < 2 doses per week within 4 weeks of screening. Neuroleptic medications and other drugs with anticholinergic properties, anti-parkinsonian medications are not allowed within 4 weeks of screening. Diuretic drugs should not be started or need to be discontinued 4 weeks prior to screening. Cholinesterase inhibitors and memantine are permitted if the doses are stable for 4 weeks prior to screening for subjects with MCI and AD. Estrogen and estrogen-like compounds and vitamin E are allowed if the dose have been stable for 4 weeks prior to screening. Participants are required to report any medication changes to the site investigators once they are enrolled in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzu-Chen YEN, MD,PhD
Phone
03-3281200
Ext
2744
Email
yen1110@adm.cgmh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Kun-Ju Lin, MD
Phone
03-32811200
Ext
2625
Email
kunjulin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzu-Chen YEN, MD,PhD
Organizational Affiliation
Nuclear Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Tzu-Chen-Yen
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun-Ju Lin, MD
Phone
03-3281200
Ext
2625
Email
kunjulin@gmail.com

12. IPD Sharing Statement

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Establish Taiwan Alzheimer's Disease Neuroimaging Initiative - a Three-year Pilot Study

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