Alzheimer DiseaseHO-MANCT06168955
Study of N-homocysteinylation of Key Proteins in Alzheimer's Disease (HO-MA)
A study testing skin biopsy in people with Alzheimer Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Alzheimer's disease (AD) is the leading cause of dementia in France. It is a multifactorial pathology, combining genetic and environmental risk factors. Homocysteine, a sulfur-containing amino acid belonging to the methionine-monocarbon cycle, has frequently been found at high levels in neurodegenerative diseases, and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2024to Dec 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age > 18 years
- Age of onset of AD < 75 years
- Person with AD with positive CSF biomarkers
- Person who has previously benefited from an analysis of AD genetic characteristics (APP, PSEN1, PSEN2, TREM2, ABCA7, SORL1 genes and ApoE status) and an analysis of monocarbon metabolism genes in the case of biochemical abnormalities by clinical exome, targeted panel or complete exome, and for whom the data set is already available.
Who cannot join
- Pregnant, parturient or breast-feeding women
- Minor (not emancipated)
- Person of legal age (subject to a legal protection measure)
- Adult unable to give consent
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Régional Universitaire de Nancy
Nancy, 54000
Mathilde Renaud, m.renaud2@chru-nancy.fr
About this study
Official title: Study of N-homocysteinylation of Key Proteins in Alzheimer's Disease
Alzheimer's disease (AD) is the leading cause of dementia in France. It is a multifactorial pathology, combining genetic and environmental risk factors. Homocysteine, a sulfur-containing amino acid belonging to the methionine-monocarbon cycle, has frequently been found at high levels in neurodegenerative diseases, and in AD in particular. It has been shown on human brain sections that the interaction of homocysteine with tau and MAP1, two key AD proteins, was significantly higher in AD patients than in controls, and corresponded to an N-homocysteinylation type interaction.
This is a prospective study, the main objective of which is to compare MAP1 N-homocysteinylation levels in fibroblasts from individuals with AD versus disease-free cell lines.
- Conditions
- Alzheimer Disease
- Being tested
- skin biopsy
- Keywords
- Alzheimer Disease, Genetic, N-homocysteinylation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyOther
skin biopsy for cell culture and N-homocysteinylation study
| Study group | Role | What they receive |
|---|---|---|
| alzheimer's disease patients | Experimental | Alzheimer's disease patients with positive biomarkers who started their disease before age 75 and benefited from genetic research. Receives: Other: skin biopsy |
| Control group | Other | control cell lines from patients free of alzheimer's disease Receives: Other: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAP1 homocysteinylation level
Measured: Baseline
Secondary outcomes (1)
Homocysteinylation level of tau protein
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study startFeb 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RENAUD Mathilde, Central Hospital, Nancy, France
- Investigators
- Mathilde Renaud, Principal investigator, Central Hospital Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168955
- Sponsor's protocol ID
- 2023-A01502-43
- Acronym
- HO-MA
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of N-homocysteinylation of Key Proteins in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06168955
- Acronym / sponsor ID
- HO-MA / 2023-A01502-43
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Genetic, N-homocysteinylation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Dec 2023 (actual)
- 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.
Alzheimer's disease (AD) is the leading cause of dementia in France. It is a multifactorial pathology, combining genetic and environmental risk factors. Homocysteine, a sulfur-containing amino acid belonging to the methionine-monocarbon cycle, has frequently been found at high levels in neurodegenerative diseases, and in AD in particular. It has been shown on human brain sections that the interaction of homocysteine with tau and MAP1, two key AD proteins, was significantly higher in AD patients than in controls, and corresponded to an N-homocysteinylation type interaction.
This is a prospective study, the main objective of which is to compare MAP1 N-homocysteinylation levels in fibroblasts from individuals with AD versus disease-free cell lines.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alzheimer's disease patients | Experimental | Other: skin biopsyAlzheimer's disease patients with positive biomarkers who started their disease before age 75 and benefited from genetic research. |
| Control group | Other | Other: skin biopsycontrol cell lines from patients free of alzheimer's disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years
- Age of onset of AD < 75 years
- Person with AD with positive CSF biomarkers
- Person who has previously benefited from an analysis of AD genetic characteristics (APP, PSEN1, PSEN2, TREM2, ABCA7, SORL1 genes and ApoE status) and an analysis of monocarbon metabolism genes in the case of biochemical abnormalities by clinical exome, targeted panel or complete exome, and for whom the data set is already available.
Key exclusion criteria (4 listed)
- Pregnant, parturient or breast-feeding women
- Minor (not emancipated)
- Person of legal age (subject to a legal protection measure)
- Adult unable to give consent
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 |
|---|---|---|
| skin biopsyskin biopsy for cell culture and N-homocysteinylation study | Other | Control group, alzheimer's disease patients |
Primary outcome
MAP1 homocysteinylation level
Time frame: Baseline
1 secondary outcome
Homocysteinylation level of tau protein
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
Mathilde Renaud principal investigator
Central Hospital Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy in people with Alzheimer Disease, run by Central Hospital, Nancy, France 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Renaud (0380425485, cppest1@chlcdijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAP1 homocysteinylation level (time frame: Baseline). 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 5 Jan 2024.