Alzheimer DiseaseHcy-MANCT05793372
Hyperhomocysteinemia in Alzheimer's Disease
An observational study of Alzheimer Disease and Homocystinemia, run by Central Hospital, Nancy, France.
Trial summary
Alzheimer's disease (AD) is the most common neurodegenerative disease. Age is its main risk factor. AD is a multifactorial disease, combining genetic and environmental risk factors. Autosomal dominant mutations have been identified (PSEN1, PSEN2, APP), leading to earlier and more severe forms of the disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, Homocystinemia
- What is being tested?
- Retrospective study of clinical features
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to 1 Mar 2026
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Alzheimer's disease with positive CSF biomarkers, age of onset < 75 years, and having already benefited from a previous research of Alzheimer's disease genetic features (PSEN1, PSEN2, APP, APOE) and homocysteine cycle (monocarbon metabolism) by complete exome/clinical exome or panel
Who may be able to join
- Clinical diagnosis of Alzheimer's disease
- Positive CSF biomarkers
- age of onset < 75 years
- already benefited from a previous research of Alzheimer's disease genetic features (PSEN1, PSEN2, APP, APOE)
- already benefited from a previous research of homocysteine cycle (monocarbon metabolism) by complete exome/clinical exome or panel
Who cannot join
- patient refusal
About this study
Alzheimer's disease (AD) is the most common neurodegenerative disease. Age is its main risk factor. AD is a multifactorial disease, combining genetic and environmental risk factors. Autosomal dominant mutations have been identified (PSEN1, PSEN2, APP), leading to earlier and more severe forms of the disease. Other genetic risk factors have been identified, such as the ε4 allele of the APOE gene. . The environment also plays a major role, with the identification of several risk factors such as air pollution or nutritional deficiencies.
AD patients frequently present hyperhomocysteinemia, a consequence of a dysfunction of monocarbon metabolism. Homocysteine is an amino acid involved in the metabolism of methionine and cysteine. High concentrations of homocysteine can be deleterious to the central nervous system.
Read more
Most prospective studies have shown that elevated homocysteine is a predictor of undefined cognitive impairment or AD. Other studies have focused on clinical data and, in particular, on cognitive function. For example, a meta-analysis found an inverse correlation between MMSE score and homocysteine level.
Thus, our study seeks to evaluate the impact of hyperhomocysteinemia on the severity and early onset of AD, while knowing the presence or absence of genetic risk factors associated with AD.
- Conditions
- Alzheimer Disease, Homocystinemia
- Being tested
- Retrospective study of clinical features
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective study of clinical featuresOther
Retrospective study of clinical features
| Study group | Role | What they receive |
|---|---|---|
| patients with Alzheimer's Disease | Patients with Alzheimer's disease Receives: Other: Retrospective study of clinical features |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between homocysteine levels and the severity/early onset of Alzheimer's disease
Mesure of homocysteine levels Mesure of MiniMental State Evaluation (MMSE), age of symptoms onset
Measured: baseline
Secondary outcomes (3)
Evaluation of the frequency of hyperhomocysteinemia in a homogeneous population of patients with Alzheimer's disease.
measurement of homocysteine levels in our cohort (µmol/L)
Measured: baseline
Evaluation of the genetic characteristics of Alzheimer's disease Evaluation of the genetic characteristics of homocysteine monocarbon metabolism.
search for an autosomal dominant mutation (APP, PSEN1 or PSEN2) or a risk factor mutation for Alzheimer's disease (TREM2, SORL1, ABCA7) and APOE status search for a mutation in the genes of monocarbon metabolism
Measured: baseline
Evaluation of the frequency of vitamin B deficiencies in a homogeneous population of patients with Alzheimer's disease.
measurement of B1,B6,B9 and B12 levels in our cohort (nmol/L)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completion1 Mar 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 43 participants (estimated)
- Target duration
- 3 Years
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793372
- Sponsor's protocol ID
- 2023PI049
- Acronym
- Hcy-MA
- Status last verified
- May 2023
- First submitted
- 20 Mar 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperhomocysteinemia in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05793372
- Acronym / sponsor ID
- Hcy-MA / 2023PI049
- Conditions
- Alzheimer Disease, Homocystinemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 31 Mar 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 most common neurodegenerative disease. Age is its main risk factor. AD is a multifactorial disease, combining genetic and environmental risk factors. Autosomal dominant mutations have been identified (PSEN1, PSEN2, APP), leading to earlier and more severe forms of the disease. Other genetic risk factors have been identified, such as the ε4 allele of the APOE gene. . The environment also plays a major role, with the identification of several risk factors such as air pollution or nutritional deficiencies.
AD patients frequently present hyperhomocysteinemia, a consequence of a dysfunction of monocarbon metabolism. Homocysteine is an amino acid involved in the metabolism of methionine and cysteine. High concentrations of homocysteine can be deleterious to the central nervous system.
Most prospective studies have shown that elevated homocysteine is a predictor of undefined cognitive impairment or AD. Other studies have focused on clinical data and, in particular, on cognitive function. For example, a meta-analysis found an inverse correlation between MMSE score and homocysteine level.
Thus, our study seeks to evaluate the impact of hyperhomocysteinemia on the severity and early onset of AD, while knowing the presence or absence of genetic risk factors associated with AD.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Alzheimer's Disease | – | Other: Retrospective study of clinical featuresPatients with Alzheimer's disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Alzheimer's disease with positive CSF biomarkers, age of onset < 75 years, and having already benefited from a previous research of Alzheimer's disease genetic features (PSEN1, PSEN2, APP, APOE) and homocysteine cycle (monocarbon metabolism) by complete exome/clinical exome or panel
Key inclusion criteria (5 listed)
- Clinical diagnosis of Alzheimer's disease
- Positive CSF biomarkers
- age of onset < 75 years
- already benefited from a previous research of Alzheimer's disease genetic features (PSEN1, PSEN2, APP, APOE)
- already benefited from a previous research of homocysteine cycle (monocarbon metabolism) by complete exome/clinical exome or panel
Key exclusion criteria (1 listed)
- patient refusal
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 |
|---|---|---|
| Retrospective study of clinical featuresRetrospective study of clinical features | Other | patients with Alzheimer's Disease |
Primary outcome
Correlation between homocysteine levels and the severity/early onset of Alzheimer's disease
Time frame: baseline
Mesure of homocysteine levels Mesure of MiniMental State Evaluation (MMSE), age of symptoms onset
3 secondary outcomes
Evaluation of the frequency of hyperhomocysteinemia in a homogeneous population of patients with Alzheimer's disease.
Time frame: baseline
Evaluation of the genetic characteristics of Alzheimer's disease Evaluation of the genetic characteristics of homocysteine monocarbon metabolism.
Time frame: baseline
Evaluation of the frequency of vitamin B deficiencies in a homogeneous population of patients with Alzheimer's disease.
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 17 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Homocystinemia, run by Central Hospital, Nancy, 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 5 inclusion and 1 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Correlation between homocysteine levels and the severity/early onset of Alzheimer's disease (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 17 May 2023.