Alzheimers disease, amyloid pathology Nervous System Diseases
Conditions
Interventions
The duration of participation of each patient is approximately four visits over 3 months. Two study arms
cutoff establishment and pivotal clinical trial. Please note that both arms have the same methodology - only the objectives and therefore the statistical analyses differ between the two arms. There is
Sponsors
Roche Diagnostics International Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 55 to 80 years old (inclusive) at the time of ICF signature 2. Has cognitive complaints or objective memory impairment and is being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline, for which the cause is yet unknown, or would be in need of referral for further cognitive evaluation 3. Quick Dementia Rating System (QDRS) score from 0.5 to 12 ( inclusive), with one box memory and recall 4. PI has uncertainty about the underlying etiology i.e. not certain that symptoms are caused by AD 5. No contraindication for performing: clinical interview, cognitive testing, blood and CSF extraction and/or amyloid PET scan 6. Has a person available to be an informant for the Clinical Dementia Rating. An informant can be any person with sufficient contact with the patient (minimum twice a week), who is willing to participate in a clinical interview for this study, is fluent in the language used during the assessment, and has sufficient cognitive health to provide accurate information. 7. Signed informed consent form
Exclusion criteria
Exclusion criteria: 1. A clinical diagnosis of moderate and severe dementia and/or Mini-Mental State Exam (MMSE) score <20 2. Has already undergone advanced diagnostic evaluation including amyloid PET and/or tau PET and/or CSF as part of their routine medical care 3. Presence of active delirium or encephalopathy 4. Shows any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and/or in their future permanence in the study 5. Has received or is receiving any investigational treatment within 5 half-lives or 6 months (whichever is longer) prior to enrollment and during the course of this study before their participation is complete 6. Has received any anti-amyloid medication in a clinical trial setting or other at any time in their life
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical performance of EAPP and pTau181p in reference to amyloid pathology status as defined by amyloid PET imaging VR. All measures are conducted at a single timepoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical performance of EAPP and pTau181p in reference to amyloid pathology status as defined by CSF biomarker analysis. All measures are conducted at a single timepoint. 2. Clinical performance of ApoE4p sub-result in reference to amyloid pathology status as defined by APOE4 genetic carrier status. All measures are conducted at a single timepoint. | — |
Countries
Australia, Austria, Denmark, England, Germany, Scotland, Spain, United Kingdom, United States of America
Contacts
Public ContactDavid Caley
Outcome results
None listed