ADNI2 Procedures Manual - DEFINING Alzheimer's Disease - Table of Contents - Protocol Overview

Oct 22, 2026

Uploaded by Franzy

ADNI2 Procedures Manual outlines defining Alzheimer’s disease and provides operational instructions for study execution. It details protocol organization, including contact information, ADCS coordinating center roles, and clinical monitoring responsibilities. The manual covers start-up and general information such as personnel requirements, site approval, MRI and PET certification, sample visit scheduling, data management, recruitment and retention, and study close-out. It further specifies screening procedures and baseline and follow-up visit timelines, plus guidance for follow-up participants and visit procedures.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages176

Reading Time7 h 24 min

AccessFree to download

Table of Contents

CONTACT INFORMATION

Protocol Staff

ADCS Coordinating Center

ADCS Clinical Monitors

PROTOCOL OVERVIEW

Protocol Summary

Schedule of Assessments

START-UP AND GENERAL INFORMATION

Personnel Requirements

Site Approval to Begin Enrollment

MRI Certification

PET Certification

Study Supplies

Data Management

Clinical Monitoring

Study Close-Out

Recruitment and Retention

NEW ENROLLEES: SCREENING PROCEDURES

Summary

Participant Identifiers

Data Flow

Screen Failures and Rescreens

Inclusion Criteria: NEW Participants

Exclusion Criteria: NEW Participants

Excluded Medications

Permitted Medications

Screening Assessments

NEW ENROLLEES: BASELINE AND FOLLOW-UP PROCEDURES

Baseline Visit

Month 3 Visit

Month 6 Visit

Annual In-Clinic Visit

6 Month Interim Telephone Check

FOLLOW-UP PARTICIPANTS: CN, LMCI, EMCI, VISIT PROCEDURES

Initial ADNI2 Visit and Follow-Up Visits

Telephone Visit Option

~~ A~~D NI 2 Defining Alzheimer's Disease PROCEDURES MANUAL Table of Contents CONTACT INFORMATION Protocol Staff........................................................................................................................................................... 1 ADCS Coordinating Center ................................................................................................................................ 2 ADCS Clinical Monitors........................................................................................................................................ 3 PROTOCOL OVERVIEW Protocol Summary ................................................................................................................................................ 4 Schedule of Assessments ................................................................................................................................... 6 START-UP AND GENERAL INFORMATION Personnel Requirements .................................................................................................................................... 9 Site Approval to Begin Enrollment.................................................................................................................. 11 MRI Certification .................................................................................................................................................... 12 PET Certification .................................................................................................................................................... 12 Study Supplies........................................................................................................................................................ 13 ADNI2 Sample Visit Schedule & General Guidelines for Scheduling Participant Visits ................ 14 Data Management ................................................................................................................................................ 15 Clinical Monitoring ............................................................................................................................................... 18 Study Close-Out..................................................................................................................................................... 19 Use of Multiple Locations at a Single Center............................................................................................... 20 Recruitment and Retention ............................................................................................................................... 20 NEW ENROLLEES: SCREENING PROCEDURES Summary .................................................................................................................................................................. 22 Participant Identifiers........................................................................................................................................... 22 Data Flow ................................................................................................................................................................. 25 Screen Failures and Rescreens.......................................................................................................................... 26 Inclusion Criteria: NEW Participants-CN, EMCI, LMCI, AD ..................................................................... 27 Exclusion Criteria: NEW Participants-CN, EMCI, LMCI, AD .................................................................... 30 Excluded Medications.......................................................................................................................................... 32 Permitted Medications ..............................................................................................................

FAQs

What sections does the manual include for protocol organization?

It includes contact information, protocol staff roles, ADCS coordinating center responsibilities, and ADCS clinical monitors. It also provides a protocol overview with protocol summary and the schedule of assessments.

What start-up tasks must be completed before enrollment begins?

The manual specifies personnel requirements, site approval to begin enrollment, MRI and PET certification, and preparation of study supplies. It also covers sample visit scheduling and general guidelines.

How are new enrollees screened and followed up?

Screening procedures include participant identifiers, data flow, rules for screen failures and rescreens, inclusion and exclusion criteria, and screening assessments such as blood draws. Baseline and follow-up procedures define baseline, month 3, month 6, annual in-clinic visits, and interim telephone checks.

Oct 22, 2026

Uploaded by Franzy