Alzheimer's dementia Alzheimer's Disease
Conditions
Interventions
None listed
Sponsors
University of Edinburgh
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age at least 50 years, checked and recorded at screening (Visit 1) only. • Fulfils the criteria set by the Balancing Committee [BC] • Able to read and write and with minimum 5 years of formal education, checked and recorded at screening (Visit 1) only. • Willing in principle to participate in the EPAD PoC trial subject to further informed consent • Have a study partner or can identify someone willing in principle to be a study partner
Exclusion criteria
Exclusion criteria: • Research participants who fulfil diagnostic criteria for any type of dementia (e.g. National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association [NINCDS-ADRDA] for AD; Lund Criteria for fronto-temporal dementia [FTD], McKeith Criteria for dementia with Lewy bodies [DLB], National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences [NINCDS-AIREN] Criteria for Vascular Dementia) • CDR >=>=1 at screening (Visit 1) • Known carriers of a Presenilin (PSEN) PSEN1, PSEN2 or APP mutation associated with Autosomal Dominant AD or any other neurodegenerative disease • 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. • Any cancer or history of cancer in the preceding 5 years (excluding cutaneous basal or squamous cell cancer resolved by excision and localised prostate cancer in male subjects) • Any current medical conditions that are clinically significant and might make the subject*s 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 re-vascularisation procedures; severe renal or hepatic failure; unstable or poorly controlled diabetesdiabetes mellitus, hypertension, or heart failure; malignant neoplasms within the last 5 years (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male subjects); any clinically relevant abnormalities in blood parameters included in local Trial Delivery CentreCentre 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 • Any contraindications for MRI/positron emission tomography (PET) scan • Any contraindications for Lumbar Puncture at visit 1. • 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. 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. • Participation in a clinical trial of an investigational product (CTIMP) in the last 30 days . Participation in a non-CTIMP or an observational arm of a CTIMP is not considered an exclusion criterion. Co-enrolment in the Amyloid Imaging to Prevent Alzheimer*s Disease (AMYPAD) Prognostic and Natural History Study (PNHS) is not considered to fall under this exclusion crite
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Seconday study outcomes: Biomarker Cerebral Spinal Fluid: Measurements will include AD-related markers (Aβ, t-tau and p-tau), and this data will be used for disease modelling and for staging of disease pathology. MRI: Hippocampal and whole brain volume; Vascular burden (WM lesions, infarcts, lacunes, microbleeds and superficial siderosis) Exploratory study outcomes: Working memory: Dot counting (NIH examiner) Choise Reaction Time and Set Shifting: (Flanker (NIH Examiner/Toolbox) Allocentric Space: Four Mountains Task (Cambridge Cognitive Neurosciences) Navigation in Egocentric Space: Virtual Reality Supermarket Trolley (University College London) Depression: 30-item Geriatric Depression Scale (GDS) Anxiety: State-Trait Anxiety Inventory (STAI) Sleep: Pittsburgh Sleep Quality Index (PSQI) Everyday functioning: Amsterdam Instrumental Activities of Daily Living Questionnaire (Amsterdam IADLQ) Exploratory neuroimaging outcomes: Structural MRI: Cortical thickness, deep grey matter volumes; Fractional anisotropy (FA) of temporal lobe, diffusion kurtosis (multi b-value DTI), network alterations Functional MRI: Global & parietal CBF; Changes within the default-mode network & relation with hippocampal activity (rsfMRI); Bolus arrival time (multi-delay ASL); Network analysis (rsfMRI) | — |
Primary
| Measure | Time frame |
|---|---|
| Neuropsychological: Verbal Episodic Memory List Learning & Story Memory (RBANS) Visual Episodic Memory Figure Recall (RBANS) Visuospatial/Constructional Figure Copy & Line Orientation (RBANS) Language Picture Naming (RBANS) Attention/Executive Functioning Semantic Fluency, Digit Span, Coding (RBANS) | — |
Countries
Netherlands
Outcome results
None listed