ADDIA Chronobiological Study

Alzheimer Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973971
• Other study ID #: ST0055
• Status: Completed
• First received: November 15, 2016
• Last updated: April 19, 2018
• Start date: November 2016
• Est. completion date: March 29, 2018

Study information

• Verified date: October 2017
• Source: Amoneta Diagnostics SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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 Aß1-42 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).

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
France	Hopitaux Universitaires de Strasbourg	Strasbourg	Alsace

Sponsors (1)

Lead Sponsor	Collaborator
Amoneta Diagnostics SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood cell biomarker level	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).	Two weeks
Secondary	Circulating biomarker level	To characterize the circulating biomarkers by assessing the effects of effect of meal, age and gender on biomarkers and changes in biomarker	two weeks