- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01465360
Performance of AclarusDx™, a Blood-Based Transcriptomic Test for AD, in US Patients Newly Referred to a Memory Center
Performance of AclarusDx™, A Blood-Based Transcriptomic Test for Alzheimer's Disease, in US-based Patients Suffering From Memory Impairment and Newly Referred to A Reference Memory Center, for AD Diagnostic Workup-A Pilot Descriptive Study
Panoramica dello studio
Stato
Descrizione dettagliata
The objective of this study is to apply AclarusDx™ signature in a reference US Center in 160 patients newly referred to one of the three study centers within the Cleveland Clinic, Center for Brain Health network, for diagnostic workup. Only AclarusDx™ will be added to the panel of tests usually performed at the centers to establish diagnosis. AclarusDx™ will be used for investigational use only, not for diagnostic purpose. The ultimate goal is to define the clinical utility of AclarusDx™ to provide Primary Care Physicians (PCPs) with a tool that will help them in making the diagnosis of Alzheimer's Disease (AD).
The primary objectives are :
- To obtain an estimate of the capability of AclarusDx™ to identify AD patients among a US-based population of newly referred patients suffering from objective memory impairment which maybe potentially related to multiple and different etiologies.
- To compare the performance of AclarusDx™ in a US-based population of newly referred patients with memory impairment with the performance of AclarusDx™ observed in one comparable European population.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Nevada
-
Las Vegas, Nevada, Stati Uniti, 89106
- Cleveland Clinic Lou Ruvo Center for Brain Health
-
-
Ohio
-
Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Center for Brain Health - Mellen Center
-
Lakewood, Ohio, Stati Uniti, 44107
- Cleveland Clinic Senior Care Assessment - Lakewood Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Male or female patient referred to the center for memory impairment.
- The memory impairment has previously been observed by a caregiver or documented by a physician.
- The memory impairment is confirmed by the memory center.
- Caucasian ethnicity.
- A written informed consent approved by an ethical review board or similar body must be obtained from the patient prior to any study-related procedures.
- If applicable, standard treatment with cholinesterase inhibitor and/or memantine is acceptable.
- Patient estimated to be compliant with study procedures.
- Patient has a level of understanding sufficient to agree to all procedures required by the protocol and must be able to cooperate. Under no circumstances will a subject who does not understand the procedure, be allowed to consent to the procedure.
Exclusion Criteria:
- Recent acute pathology or medical condition or surgery which may alter the inflammatory homeostasis, according to the opinion of the investigator.
- Non-Caucasian ethnicity.
- Patient with severe uncontrolled or unstable medical condition.
- Need for a legal representative for the medical condition of the patient.
- Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator.
- Current or recent history (within one month) of clinically significant pathology, medical condition (including hospitalization) or symptoms. However, chronic diseases or medical conditions that are considered stable are accepted, provided that they are compatible with other study selection criteria.
- Current or recent history of drug or alcohol abuse or dependence.
- Current, clinically significant major psychiatric disorder (eg, major depressive disorder) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition text revised (DSM-IV TR), or significant symptoms (eg, hallucinations).
- Woman of childbearing potential is not allowed to participate in the study. (A woman of childbearing potential is a woman who is biologically capable of becoming pregnant).
- Current participation in another study using an investigational non-marketed product.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
---|
Study patients
Patients newly referred to a Reference Memory Center with a complaint of memory impairment for AD diagnostic workup.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sensitivity of AclarusDx™ in AD patients
Lasso di tempo: Outcome measured during one single study visit
|
The determination of the sensitivity of the test, being the percentage of positive AclarusDx™ calls among referred patients being confirmed clinically as having AD at the Memory Center will be calculated.
|
Outcome measured during one single study visit
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Charles B. Bernick, MD, Cleveland Clinic Lou Ruvo Center for Brain Health
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Malattia cardiovascolare
- Malattie vascolari
- Malattie metaboliche
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Arteriosclerosi
- Malattie arteriose occlusive
- Manifestazioni neurologiche
- Manifestazioni neurocomportamentali
- Disturbi neurocognitivi
- Malattie parkinsoniane
- Malattie dei gangli basali
- Disturbi del movimento
- Sinucleinopatie
- Malattie Neurodegenerative
- TDP-43 Proteinopatie
- Carenze di proteostasi
- Tauopatie
- Disturbi cognitivi
- Disturbi del linguaggio
- Disturbi della comunicazione
- Malattie arteriose intracraniche
- Disturbi del linguaggio
- Degenerazione lobare frontotemporale
- Arteriosclerosi intracranica
- Leucoencefalopatie
- Morbo di Parkinson
- Demenza
- Malattia di Alzheimer
- Disfunzione cognitiva
- Afasia
- Demenza frontotemporale
- Afasia, primaria progressiva
- Scegli Malattia del cervello
- Demenza, Vascolare
Altri numeri di identificazione dello studio
- EHTAD/003
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .