Clinical trial: European Prevention of Alzheimer's Dementia (EPAD) Longitudinal Cohort Study (LCS) (NCT02804789)

Eligibility criteria:
Inclusion Criteria:

          1. At least 50 Years of Age

          2. Characterisation of cognitive, biomarker and risk factors (genetic, environmental)
             status of research participants based on data collected at the EPAD screening/baseline
             visit, so that decisions on selection/deselection can be made with reference to the
             dual needs of having sufficient heterogeneity across the entire probability-spectrum
             population for disease-modelling work, and suitable research participants for the EPAD
             PoC trial (Balancing Committee decision)

          3. Able to read and write with a minimum of 7 years of formal education.

          4. Willing in principle to participate in the EPAD Proof of Concept Trials (with
             additional consent).

          5. Have a study partner or can identify someone willing to be a study partner. The
             primary role of the study partner will be as informant. They will also receive oral
             and written information about the EPAD LCS, and will sign an Informed Consent Form
             (ICF).

        Exclusion Criteria:

          1. Individuals who fulfill diagnostic criteria for any type of dementia.

          2. Clinical Dementia Rating >=1

          3. Known carriers of a Presenilin (PSEN) 1, PSEN 2 or Amyloid Precursor Protein (APP)
             mutation associated with Autosomal Dominant Alzheimer's dementia or any other
             neurodegenerative disease.

          4. Presence of any neurological, psychiatric or medical conditions associated with a
             long-term risk of significant cognitive impairment or dementia including but not
             limited to pre- manifest Huntington's disease, multiple sclerosis, Parkinson's
             disease, Down syndrome, active alcohol/drug abuse; or major psychiatric disorders
             including current major depressive disorder, schizophrenia, schizoaffective or bipolar
             disorder.

          5. Cancer or history of cancer in the last 5 years (excluding cutaneous basal or squamous
             cell cancer resolved by excision).

          6. Any current medical conditions that are clinically significant and might make
             participation in an investigational trial unsafe, e.g., uncontrolled or unstable
             disease of any major organ system; history within the last 6 months of any acute
             illness of a major organ system requiring emergency care or hospitalization, including
             revascularization procedures; severe renal or hepatic failure; unstable or poorly
             controlled DM, hypertension, or heart failure; malignant neoplasms within the last 3
             years (expect for basal or squamous cell carcinoma in situ of the skin, or localized
             prostate cancer in male participants); any clinically relevant abnormalities in blood
             parameters included in local TDC routine assessments; severe loss of vision, hearing
             or communicative ability; or any conditions preventing co-operation or completion of
             the required assessments in the trial, as judged by the investigator.

          7. Contraindications for MRI/Positron emission tomography (PET) Scan.

          8. Contraindications for Lumbar Puncture.

          9. Any evidence of intracranial pathology which, in the opinion of the Investigator, may
             affect cognition including but not limited to brain tumours (benign or malignant),
             aneurysm or arteriovenous malformations, territorial stroke (excluding smaller
             watershed strokes), recent haemorrhage (parenchymal or subdural), or obstructive
             hydrocephalus. Research participants with a MRI scan demonstrating markers of small
             vessel disease (e.g. white matter changes or lacunar infarcts) judged to be clinically
             insignificant, or microbleeds are allowed.

         10. Participation in a clinical trial of an Investigational Product (CTIMP) in the last 30
             days (continued participation in the parent cohort is expected). Participation in a
             non-CTIMP is not an exclusion criterion.

        Diminished decision-making capacity/ not capable of consenting at Visit 1 or Visit 2. If at
        a subsequent annual EPAD LCS visit health professionals suspect diminished consent capacity
        according to local TDC routine procedures, a formal assessment of the research
        participant's capacity to consent will be conducted. The participant will be offered the
        opportunity to continue in the EPAD LCS under suitable local regulations regarding
        capacitous participants who have consented to enter a longitudinal study who subsequently
        loose capacity. Capacity will be assessed at each study visit using the correct legal
        framework.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.


Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? 0