Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the performance of AclarusDx™, an investigational blood test detecting gene expression information, and intended to help physicians in making an Alzheimer's Disease diagnosis in patients having memory complaint and/or cognitive impairments.


Clinical Trial Description

The objective of this study is to apply AclarusDx™ signature in 600 patients newly referred in french memory centers. 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 physicians with a tool that will help them in making the diagnosis of Alzheimer's Disease (AD).

The primary objective is to estimate the prevalence of positive AclarusDx™ in patients diagnosed AD in the population of primary consultants. This population of primary consultants consists of patients with cognitive impairment and / or a memory complaint requiring specialized exploration using AclarusDx™ blood test and which may be potentially related to multiple and different etiologies.

The secondary objectives are:

- Assess the prevalence of positive AclarusDx™ in relation to other diagnoses (MCI, vascular dementia ...) established by the physician investigator at the end of specialized assessment.

- Identify the demographic factors anamnestic, clinical, biological and imaging associated with positivity of AclarusDx™

- Identify the demographic factors anamnestic, clinical, biological and imaging associated with the diagnosis of AD and other diagnoses.

- Determine the contribution of AclarusDx™ in the usual battery of tests performed for diagnostic approach to Alzheimer's disease and to identify a possible association of interest with one or more endpoints (clinical, neuropsychological, brain, biological imaging).

- Assess: diagnostic status at 6 and 12 months, and the MMSE and IADL at 6 and 12 months.

- assess the predictive value of AclarusDx™ achieved during the initial visit to the diagnosis of AD is 12 months.

- Evaluate AclarusDx™ predictive value to 12 months ;


Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT02221661
Study type Observational [Patient Registry]
Source Diaxonhit
Contact
Status Completed
Phase N/A
Start date December 2011
Completion date December 2013

See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Recruiting NCT04356924 - Psychological Treatment to Support the Consequences of Cognitive Impairment N/A
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Terminated NCT04493957 - Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT04426838 - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad N/A
Completed NCT04713384 - Remote Bimanual Virtual Rehabilitation Post CVD N/A
Recruiting NCT06284213 - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting NCT06053775 - Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP) N/A
Completed NCT03698695 - A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers Phase 1
Not yet recruiting NCT05552729 - Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors Phase 1/Phase 2
Recruiting NCT03268109 - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed NCT03301402 - Air Purifier to Improve Endothelial Function and Carotid Intima Thickness N/A
Completed NCT03187353 - IMProving Executive Function Study Phase 4
Completed NCT05395559 - Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
Recruiting NCT05030285 - Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment N/A
Recruiting NCT04897334 - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke N/A
Recruiting NCT04907565 - Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue