8. Assessment Schedule

8.1 Pre – assessment screening

Patients who agree to participate in the study must fulfil all eligibility criteria. A screening checklist will be completed and a Patient Eligibility Screening Form (ESF) will be completed.

The following information will be contained in the ESF:

• Patient Identification: Name, date of birth, and Patient Identification Number (PIN). This PIN is a unique number allocated to each patient that will be used for identification of each subject throughout the study. The patients name will only be recorded on the ESF and not recorded elsewhere.
• Eligibility Screening: Checklist of inclusion and exclusion criteria.
• Eligibility statement: Documentation of eligibility.
• Signature and Date: Assessor to sign and date form and then file.
• The ESF for each patient will be kept on file along with other patient documentation
  relevant to the study.
• Capacity statement: Documentation that patient has capacity to consent to participate.
• Category allocation: Documentation of which category the patients belongs to:

           >65 but <90 years diagnosed with possible/ mild Alzheimer’s Disease.
           > 65 but <90 years with mild cognitive impairment (MCI).
           >45 but <65 years with cognitive deficits/ early onset neurodegeneration.

Subjects that are eligible and wish to participate in the study will have an initial screening visit where they will be furnished with all relevant study documentation, including the patient information leaflet (PIL) and consent forms. The information will be discussed individually with each patient in person and a period of five days must be provided to each potential subject to allow them time to consider the information before written consent is obtained.

8.2 Schedule of Assessments

There will be a total of two visits annually as long as the participant is enrolled in the study.

Visit 1 (Year 1) must only occur at least 5 days post the screening visit.

8.2.1 Visit 1:

Subject will provide written consent to participate in the study.
The battery of cognitive tests will be performed:

• RBANS  (Repeatable Battery for Assessment of Neurological Status)
• CAMCOG  (Cambridge Cognitive Examination)
• MoCA (Montreal Cognitive Assessment)
• CESD  (Centre for Epidemiological Studies Depression scale)
• B-ADL (Bristol Activities of Daily Living)
• CDR    (Clinical Dementia Rating Scale)

8.2.2 Visit 2:

At the second visit the subject will undergo a research lumber puncture and blood draw.

The lumber puncture will be performed as per the Standard Operating Procedure (SOP).
The LP will be performed for measurement of CSF biomarkers: P-tau, T-tau & Aβ 42.

The blood test will be performed as per the Standard Operating Procedure (SOP).
The blood draw is be taken for:

• Paired blood test for albumin CSF- to- serum ratio.  
• Blood Biomarker Analysis
• APOE genotyping.
• Results from both cognitive and physiological tests will be recorded under the PIN and filed in each subject’s study file on site. Because the CSF biomarkers are taken for research purposes, the results of the testing carried out in the research laboratory will not be disclosed to patients for diagnostic purposes.