Protocol

A pilot study on the utility of CSF and blood biomarkers in the delineation of the aetiopathology of cognitive impairment and in the prediction of conversion of mild cognitive impairment to dementia.

This study is being conducted as part of a large EC funded project called BIOMARKAPD.

CONTENTS

1. STUDY SUMMARY
1.1 Title
1.2 Design
1.3 Objectives
1.4 Population
1.5 Eligibility
1.6 Study Duration

2. BACKGROUND AND RATIONALE OF STUDY
  2.1 Joint Programming on Neurodegeneration Diseases (JPND)
  2.2 BIOMARKAPD
  2.3 BIOMARKAPD Collaboration
  2.4 Description of Irish Study
  2.5 Study Background

3. OBJECTIVES OF STUDY
    3.1 Study Aims
    3.2 Study Endpoints

4. PATIENT SELECTION CRITERIA
    4.1 Inclusion Criteria
    4.2 Exclusion Criteria
    4.3 Control Study Subjects

5. CONSENT
    5.1 Capacity to consent
    5.2 Consent Forms

6. STUDY DESIGN AND METHODOLOGY
    6.1 Design and Methodology
    6.2 Number of Subjects
    6.3 Sample Size
    6.4 Study Sites
          6.4.1 St James Hospital- Main Study Site
          6.4.2 Future Potential Study Sites

7. STUDY ASSESSMENTS & PROCEDURES
    7.1 Summary of Study Assessment
    7.2 Standard Operating Procedure (SOP) for CSF Collection
    7.3 Standard Operating Procedure (SOP) for Blood Collection
          7.3.1 Plasma Collection SOP
          7.3.2 Serum Collection SOP
    7.4 Summary of Cognitive Testing Battery
          7.1.1 Repeatable Battery for Assessment of Neurological Status (RBANS)
          7.1.2 Cambridge Cognitive Examination (CAMCOG)
          7.1.3 Montreal Cognitive Assessment (MoCA)
          7.1.4 Centre for Epidemiological Studies Depression Scale (CEDS)
          7.1.5 Bristol Activities of Daily Loving (B- ADL)
          7.1.6 Clinical Dementia Rating Scale (CDR)

8. ASSESSMENT SCHEDULE
     8.1 Pre- assessment screening
     8.2 Schedule of Assessments
          8.2.1 Visit 1
          8.2.2 Visit 2

9. BIOMARKER ANALYSIS
    9.1 BIOMARKAPD Biobanking Requirements

10.CONGITIVE TESTING SCORES ANALYSIS
   
11.FOLLOW UP & MONITORING
      11.1 Category 1: Possible Alzheimer’s Disease
      11.2 Category 2: Mild Cognitive Impairment
      11.3 Category 3: Early Onset Neurodegeneration
      11.4 Repeat Assessment- Year 2 & Year 3

12.PATIENT WTHDRAWAL FROM STUDY
     12.1 Scheduled termination
     12.2 Unscheduled termination

13.REFERENCES

14. APPENDICES
     Appendix A: Consent Form 1: Use of clinical information for research purposes
     Appendix B: Consent Form 2: Blood test for biomarkers and albumin
     Appendix C: Consent Form 3: Blood test for genotyping
     Appendix D: Consent Form 4: Lumber Puncture for biomarkers
     Appendix E: NINCDS-ADRDA criteria for Probable Alzheimer’s disease
     Appendix F: Patient Information Leaflet ( PIL)
     Appendix G: Patient Eligibility Screening Form (ESF)