European Prevention of Alzheimer's Dementia - Longitudinal Cohort Study (EPAD-LCS)

Completed

• Conditions: Alzheimer's Disease; Alzheimer's dementia; 10029305; 10012272

• Registration Number: NL-OMON47731
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

• 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Neuropsychological:<br /><br>Verbal Episodic Memory List Learning & Story Memory (RBANS)<br /><br>Visual Episodic Memory Figure Recall (RBANS)<br /><br>Visuospatial/Constructional Figure Copy & Line Orientation (RBANS)<br /><br>Language Picture Naming (RBANS)<br /><br>Attention/Executive Functioning Semantic Fluency, Digit Span, Coding (RBANS)</p><br>