"Alzheimer's Disease" and "Lewy Body Disease"AlphaLewyMaNCT01876459
Alpha-synuclein in Cerebrospinal Fluid to Differentiate Alzheimer's Disease From Lewy Body Disease.
A study testing MRI, lumbar puncture and neuropsychological tests in people with "Alzheimer's Disease" and "Lewy Body Disease", run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Patients with memory disorders are experiencing different trends which are difficult to predict. Moreover, the distinction between Lewy body disease and Alzheimer's disease is not easy as both diseases can present similar symptoms. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- "Alzheimer's Disease" and "Lewy Body Disease"
- What is being tested?
- MRI, lumbar puncture and neuropsychological tests
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Apr 2015
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 45 years of age
- Subject agrees to participate in the study
- Subject meets the criteria Dubois et al., 2007. for diagnosis of probable AD.
- Subject with a syndromic presentation of mild cognitive impairment or mild dementia
- Subject has a study partner who is able to provide accurate information about the patient
- Subject affiliated to a social security scheme
Who cannot join
- Patient who meets both AD and Lewy Body disease criteria
- Contraindications to lumbar puncture
- Contraindications to an MRI scan
- Subject who is not affiliated to a social security scheme
- Subject under guardianship or curatorship
- Subject under judicial protection
Show all 11Show fewer
- Subject refuses to participate in the study
- Subject has evidence of clinically relevant neurological disorder (fronto-temporal dementia, brain tumor, stroke, …) that led to persistent cognitive disorders
- Subject has evidence of clinically relevant psychiatric disorders (schizophrenia, major depression, …)
- Pregnant or attempting to become pregnant women
- Subject's vision and audition is sufficient for neuropsychological tests's assessment, based on the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, Hôpital de Hautepierre, 67098
Frédéric BLANC, Docteur, 3 88 12 86 38 ext. 0033, frederic.blanc@chru-strasbourg.fr
Frédéric BLANC, Docteur
About this study
Official title: Rate of Alpha-synuclein in Cerebrospinal Fluid to Differentiate Patient With Alzheimer's Disease From Those With Lewy Body Disease.
Patients with memory disorders are experiencing different trends which are difficult to predict. Moreover, the distinction between Lewy body disease and Alzheimer's disease is not easy as both diseases can present similar symptoms. Nowadays, routine examinations exist and can improve the diagnosis but there are not specific enough of one of those two pathologies.
Lewy body disease is characterized by the presence of particular structures in patient's brain, called "Lewy body", composed of a protein called "alpha-synuclein". The aim of this study is to measure the rate of alpha-synuclein in cerebrospinal fluid. This measurement could allow us to differentiate patient with Alzheimer's disease from those with Lewy body disease.
- Being tested
- MRI, lumbar puncture, neuropsychological tests
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
lumbar punctureProcedure or surgery
neuropsychological testsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| "Alzheimer's Disease" arm | Other | Patient with Alzheimer's disease Receives: Other: MRI; Procedure: lumbar puncture; Behavioral: neuropsychological tests |
| "Lewy Body Disease" arm | Other | Patient with Lewy Body Disease Receives: Other: MRI; Procedure: lumbar puncture; Behavioral: neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of alpha-synuclein in cerebrospinal fluid
Measured: Day one.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for "Alzheimer's Disease" and "Lewy Body Disease"Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876459
- Sponsor's protocol ID
- 5330
- Other IDs
- N° IDRCB 2012-A00992-41
- Acronym
- AlphaLewyMa
- Status last verified
- Jun 2013
- First submitted
- 10 Jun 2013
- Last updated
- 18 Jun 2013
- Results posted
- No
Publications
Gabriel V, Chabran E, Sourty M, Cretin B, Philippi N, Muller C, Anthony P, Demuynck C, Loureiro de Sousa P, Botzung A, Sanna L, Bousiges O, Blanc F. Salience and frontoparietal network impairments across disease stages in dementia with Lewy bodies: A comparative functional MRI study with Alzheimer's disease. J Alzheimers Dis. 2025 Dec;108(3):1398-1409. doi: 10.1177/13872877251386844. Epub 2025 Oct 17.
PubMed 41105629Querry M, Botzung A, Sourty M, Chabran E, Sanna L, Loureiro de Sousa P, Cretin B, Demuynck C, Muller C, Ravier A, Schorr B, Philippi N, Blanc F. Functional Connectivity Changes Associated With Depression in Dementia With Lewy Bodies. Int J Geriatr Psychiatry. 2025 Mar;40(3):e70058. doi: 10.1002/gps.70058.
PubMed 40011213Sainsily-Cesarus A, Schmitt E, Landre L, Botzung A, Rauch L, Demuynck C, Philippi N, de Sousa PL, Mutter C, Cretin B, Martin-Hunyadi C, Blanc F. Dementia with Lewy bodies and gait neural basis: a cross-sectional study. Alzheimers Res Ther. 2024 Jul 30;16(1):170. doi: 10.1186/s13195-024-01539-z.
PubMed 39080741Bousiges O, Cretin B, Muller C, Botzung A, Sanna L, Anthony P, Philippi N, Demuynck C, Blanc F. Involvement of ApoE4 in dementia with Lewy bodies in the prodromal and demented stages: evaluation of the Strasbourg cohort. Geroscience. 2024 Apr;46(2):1527-1542. doi: 10.1007/s11357-023-00883-6. Epub 2023 Aug 31.
PubMed 37653269Mendes A, Noblet V, Mondino M, Loureiro de Sousa P, Manji S, Archenault A, Casanovas M, Bousiges O, Philippi N, Baloglu S, Rauch L, Cretin B, Demuynck C, Martin-Hunyadi C, Blanc F. Association of cerebral microbleeds with cerebrospinal fluid Alzheimer-biomarkers and clinical symptoms in early dementia with Lewy bodies. Int J Geriatr Psychiatry. 2021 Jun;36(6):851-857. doi: 10.1002/gps.5485. Epub 2020 Dec 26.
PubMed 33300151Bousiges O, Philippi N, Lavaux T, Perret-Liaudet A, Lachmann I, Schaeffer-Agalede C, Anthony P, Botzung A, Rauch L, Jung B, de Sousa PL, Demuynck C, Martin-Hunyadi C, Cretin B, Blanc F. Differential diagnostic value of total alpha-synuclein assay in the cerebrospinal fluid between Alzheimer's disease and dementia with Lewy bodies from the prodromal stage. Alzheimers Res Ther. 2020 Sep 29;12(1):120. doi: 10.1186/s13195-020-00684-5.
PubMed 32993772
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Alpha-synuclein in Cerebrospinal Fluid to Differentiate Patient With Alzheimer's Disease From Those With Lewy Body Disease.
- ClinicalTrials.gov ID
- NCT01876459
- Acronym / sponsor ID
- AlphaLewyMa / 5330
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 12 Jun 2013 (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.
Patients with memory disorders are experiencing different trends which are difficult to predict. Moreover, the distinction between Lewy body disease and Alzheimer's disease is not easy as both diseases can present similar symptoms. Nowadays, routine examinations exist and can improve the diagnosis but there are not specific enough of one of those two pathologies.
Lewy body disease is characterized by the presence of particular structures in patient's brain, called "Lewy body", composed of a protein called "alpha-synuclein". The aim of this study is to measure the rate of alpha-synuclein in cerebrospinal fluid. This measurement could allow us to differentiate patient with Alzheimer's disease from those with Lewy body disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Alzheimer's Disease" arm | Other | Other: MRI, Procedure: lumbar puncture, Behavioral: neuropsychological testsPatient with Alzheimer's disease |
| "Lewy Body Disease" arm | Other | Other: MRI, Procedure: lumbar puncture, Behavioral: neuropsychological testsPatient with Lewy Body Disease |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 45 years of age
- Subject agrees to participate in the study
- Subject meets the criteria Dubois et al., 2007. for diagnosis of probable AD.
- Subject with a syndromic presentation of mild cognitive impairment or mild dementia
- Subject has a study partner who is able to provide accurate information about the patient
Key exclusion criteria (11 listed)
- Patient who meets both AD and Lewy Body disease criteria
- Contraindications to lumbar puncture
- Contraindications to an MRI scan
- Subject who is not affiliated to a social security scheme
- Subject under guardianship or curatorship
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 |
|---|---|---|
| MRI | Other | "Alzheimer's Disease" arm, "Lewy Body Disease" arm |
| lumbar puncture | Procedure or surgery | "Alzheimer's Disease" arm, "Lewy Body Disease" arm |
| neuropsychological tests | Behavioural | "Alzheimer's Disease" arm, "Lewy Body Disease" arm |
Primary outcome
rate of alpha-synuclein in cerebrospinal fluid
Time frame: Day one.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
- Derived from this study: PubMed 41105629Gabriel V, Chabran E, Sourty M, Cretin B, Philippi N, Muller C, Anthony P, Demuynck C, Loureiro de Sousa P, Botzung A, Sanna L, Bousiges O, Blanc F. Salience and frontoparietal network impairments across disease stages in dementia with Lewy bodies: A comparative functional MRI study with Alzheimer's disease. J Alzheimers Dis. 2025 Dec;108(3):1398-1409. doi: 10.1177/13872877251386844. Epub 2025 Oct 17.
- Derived from this study: PubMed 40011213Querry M, Botzung A, Sourty M, Chabran E, Sanna L, Loureiro de Sousa P, Cretin B, Demuynck C, Muller C, Ravier A, Schorr B, Philippi N, Blanc F. Functional Connectivity Changes Associated With Depression in Dementia With Lewy Bodies. Int J Geriatr Psychiatry. 2025 Mar;40(3):e70058. doi: 10.1002/gps.70058.
- Derived from this study: PubMed 39080741Sainsily-Cesarus A, Schmitt E, Landre L, Botzung A, Rauch L, Demuynck C, Philippi N, de Sousa PL, Mutter C, Cretin B, Martin-Hunyadi C, Blanc F. Dementia with Lewy bodies and gait neural basis: a cross-sectional study. Alzheimers Res Ther. 2024 Jul 30;16(1):170. doi: 10.1186/s13195-024-01539-z.
- Derived from this study: PubMed 37653269Bousiges O, Cretin B, Muller C, Botzung A, Sanna L, Anthony P, Philippi N, Demuynck C, Blanc F. Involvement of ApoE4 in dementia with Lewy bodies in the prodromal and demented stages: evaluation of the Strasbourg cohort. Geroscience. 2024 Apr;46(2):1527-1542. doi: 10.1007/s11357-023-00883-6. Epub 2023 Aug 31.
- Derived from this study: PubMed 33300151Mendes A, Noblet V, Mondino M, Loureiro de Sousa P, Manji S, Archenault A, Casanovas M, Bousiges O, Philippi N, Baloglu S, Rauch L, Cretin B, Demuynck C, Martin-Hunyadi C, Blanc F. Association of cerebral microbleeds with cerebrospinal fluid Alzheimer-biomarkers and clinical symptoms in early dementia with Lewy bodies. Int J Geriatr Psychiatry. 2021 Jun;36(6):851-857. doi: 10.1002/gps.5485. Epub 2020 Dec 26.
- Derived from this study: PubMed 32993772Bousiges O, Philippi N, Lavaux T, Perret-Liaudet A, Lachmann I, Schaeffer-Agalede C, Anthony P, Botzung A, Rauch L, Jung B, de Sousa PL, Demuynck C, Martin-Hunyadi C, Cretin B, Blanc F. Differential diagnostic value of total alpha-synuclein assay in the cerebrospinal fluid between Alzheimer's disease and dementia with Lewy bodies from the prodromal stage. Alzheimers Res Ther. 2020 Sep 29;12(1):120. doi: 10.1186/s13195-020-00684-5.
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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.
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, lumbar puncture and neuropsychological tests in people with "Alzheimer's Disease" and "Lewy Body Disease", run by University Hospital, Strasbourg, 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 6 inclusion and 11 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 18 Jun 2013. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of alpha-synuclein in cerebrospinal fluid (time frame: Day one.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01876459, which also lists 6 linked publications.
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 18 Jun 2013.