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ADDIA Chronobiological Study

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ClinicalTrials.gov Identifier: NCT02973971
Recruitment Status : Completed
First Posted : November 28, 2016
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Amoneta Diagnostics SAS

Brief Summary:
The present single center clinical chronobiological study on 24 subjects (12 patients with mild to moderate form of Alzheimer's disease and 12 Healthy subjects) aims at characterizing the ADDIA biomarkers: a) blood cell-based biomarkers measured by flow cytometry using proprietary probes specific of two targeted biomarkers, beta-Amyloid (Aβ) peptide and a kinase, and b) circulating biomarkers in peripheral body fluids. The biomarkers will be analyzed on samples taken at different time points of the day, including under fasting and non-fasting conditions and at two periods: day 1 and day 14.

Condition or disease
Alzheimer Disease

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study on Patients With Mild to Moderate Form of Alzheimer's Disease and Healthy Volunteers: Characterization of Intra-subject Variability and Chronobiological Variations of ADDIA Biomarkers.
Study Start Date : November 2016
Actual Primary Completion Date : March 29, 2018
Actual Study Completion Date : March 29, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Healthy subjects
Alzheimer patients



Primary Outcome Measures :
  1. Blood cell biomarker level [ Time Frame: Two weeks ]
    To characterize the targeted blood cell biomarkers by assessing the effects of effect of meal, age and gender on biomarkers and changes in biomarker expression levels over two periods (day 1, day 15).


Secondary Outcome Measures :
  1. Circulating biomarker level [ Time Frame: two weeks ]
    To characterize the circulating biomarkers by assessing the effects of effect of meal, age and gender on biomarkers and changes in biomarker


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • 12 patients with mild to moderate form of Alzheimer's disease 55 to 85 years-old.
  • 12 healthy volunteers (HV), 55 to 85 years-old.
  • Total expected completed subjects: 24.
  • Stratification by gender: 6 males and 6 females, age-matched healthy subjects and 6 males and 6 females, age-matched Alzheimer patients.
  • Mean age similar in both groups
Criteria

Inclusion Criteria for Alzheimer patient group:

  • Signed Informed Consent.
  • Male or female subject, between 55 and 85 years inclusive.
  • Specific clinical phenotype of AD: Presence of an early and significant episodic memory impairment (isolated or associated with other cognitive or behavioural changes that are suggestive of a dementia syndrome) that includes the following:

    • Gradual and progressive change in memory function reported by patient or informant over more than 6 months.
    • Objective evidence of an amnesic syndrome of hippocampal type, based on significantly impaired performance on an episodic memory test with established specificity for mild to moderate AD.
  • Cognitive tests including MMSE score 12 ≤ MMSE ≤ 25 for mild to moderate AD (measured in the last 3 months), b) Scores of other tests routinely practiced at the hospital for measurement of memory and cognition shall be compatible with mild to moderate AD.
  • Neuroimaging compatible with a diagnosis of mild to moderate AD.
  • Cerebrospinal fluid (CSF) biomarkers showing at least 2 positive levels out of the 3 biomarkers: CSF Aβ1-42 and tau (Phosphorylated-Tau and/or Total-Tau). CSF collection and data being only retrospective.

Inclusion Criteria for healthy controls:

  • Signed Informed Consent.
  • Male or female subject, between 55 and 85 years inclusive.
  • Normal clinical and cognitive scores as measured using standard neuropsychological tests.
  • Normal scores in other neuropsychological tests routinely practiced at the hospital for measurement of memory and cognition.
  • No abnormal neuroimaging findings in at least structural MRI.

Exclusion Criteria:

  • Any subject who did not sign the informed consent form.
  • Any chronic neurodegenerative disease (vascular dementia, Parkinson's disease, Creutzfeldt Jacob, Huntington's disease, etc.), acute neurodegenerative disease (stroke), history or presence of clinically relevant psychiatric history (schizophrenia, psychosis), some chronic inflammatory diseases that impact blood cells (e.g. anemia of inflammation and chronic disease) and some cancers (that impact blood cells: e.g. leukemia), major sensory deficits that could interfere with cognitive assessment (visual and auditory), epilepsy.
  • Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
  • Blood donation, any volume, within 2 months before inclusion.
  • Neutropenia (Neutrophils < 1500/mm3).
  • Thrombocytopenia (platelets: < 100,000/mm3, rule out EDTA-induced pseudothrombocytopenia).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973971


Locations
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France
Hopitaux Universitaires de Strasbourg
Strasbourg, Alsace, France
Sponsors and Collaborators
Amoneta Diagnostics SAS
Investigators
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Principal Investigator: Frédéric Blanc, MD Hôpitaux Strasbourg
Principal Investigator: Catherine Mutter, MD Hôpitaux Strasbourg
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Responsible Party: Amoneta Diagnostics SAS
ClinicalTrials.gov Identifier: NCT02973971    
Other Study ID Numbers: ST0055
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: October 2017
Keywords provided by Amoneta Diagnostics SAS:
Blood cell biomarkers, peripheral circulating biomarkers
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders