Alzheimer DiseaseNCT02973971
ADDIA Chronobiological Study
An observational study of Alzheimer Disease, run by Amoneta Diagnostics SAS at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- volumeric MRI
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to 29 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Alzheimer Disease
- Being tested
- volumeric MRI
- Keywords
- Blood cell biomarkers, peripheral circulating biomarkers
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volumeric MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described Receives: Other: volumeric MRI | |
| Alzheimer patients | Not described Receives: Other: volumeric MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Two weeks
Secondary outcomes (1)
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
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amoneta Diagnostics SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric Blanc, MD, Principal investigator, Hôpitaux StrasbourgCatherine Mutter, MD, Principal investigator, Hôpitaux Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973971
- Sponsor's protocol ID
- ST0055
- Status last verified
- Sep 2024
- First submitted
- 15 Nov 2016
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02973971
- Acronym / sponsor ID
- ST0055
- Conditions
- Alzheimer Disease
- Keywords
- Blood cell biomarkers, peripheral circulating biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Amoneta Diagnostics SASIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: volumeric MRI |
| Alzheimer patients | – | Other: volumeric MRI |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| volumeric MRI | Other | Alzheimer patients, Healthy subjects |
Primary outcome
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).
1 secondary outcome
Circulating biomarker level
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Blanc, MD principal investigator
Hôpitaux Strasbourg
Catherine Mutter, MD principal investigator
Hôpitaux Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Amoneta Diagnostics SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood cell biomarker level (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.