Alzheimer DiseaseADAB40NCT02770482
Amyloid Beta-peptide 1-40 and Alzheimer's Disease
A study testing spinal fluid collection in people with Alzheimer Disease, run by CHU de Reims at 1 site in France.
Trial summary
The combined measurement of Ab42 and tau protein (total and phosphorylated) in the spinal fluid has been shown to be promising in the diagnosis of Alzheimer's disease (AD), and has justified its inclusion new diagnostic criteria. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- spinal fluid collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to 14 Mar 2018
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients attending the Memory Clinic of Champagne-Ardennes for memory disorders, and
- Whose diagnostic work-up requires assessment of biomarkers present in the cerebrospinal fluid are considered eligible for inclusion in this study.
Who cannot join
- Patients who do not have any social security coverage will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of Amyloid Beta-peptide 1-40 Measurement in the Diagnosis of Alzheimer's Disease
The combined measurement of Ab42 and tau protein (total and phosphorylated) in the spinal fluid has been shown to be promising in the diagnosis of Alzheimer's disease (AD), and has justified its inclusion new diagnostic criteria. However, it can sometimes yield discordant results that are not discriminant (isolated variation in Ab42 or P-181 Tau). To answer this challenge, a new marker has been developed in recent years, namely amyloid beta-peptide 1-40 (Aβ40). This marker reflects the patient's total amyloid deposits and is used to calculate the Aβ42/Aβ40 ratio. This ratio measures the relative variation of Aβ42 as compared to the total amyloid burden. Literature data on this topic are sparse and to date, no report has been published evaluating the utility of this marker in the diagnostic strategy for AD.
- Conditions
- Alzheimer Disease
- Being tested
- spinal fluid collection
- Keywords
- dementia, biomarkers, cerebrospinal fluid
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal fluid collectionBiological
| Study group | Role | What they receive |
|---|---|---|
| AD Patients | Experimental | Not described Receives: Biological: spinal fluid collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of diagnostic certitude for AD (diagnosed cases)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startJun 2014
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770482
- Sponsor's protocol ID
- PA13050
- Acronym
- ADAB40
- Status last verified
- Jun 2020
- First submitted
- 31 Mar 2015
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Kisserli A, Tabary T, Cohen JHM, Duret V, Mahmoudi R. High-resolution Melting PCR for Complement Receptor 1 Length Polymorphism Genotyping: An Innovative Tool for Alzheimer's Disease Gene Susceptibility Assessment. J Vis Exp. 2017 Jul 18;(125):56012. doi: 10.3791/56012.
PubMed 28745649
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Amyloid Beta-peptide 1-40 Measurement in the Diagnosis of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02770482
- Acronym / sponsor ID
- ADAB40 / PA13050
- Conditions
- Alzheimer Disease
- Keywords
- dementia, biomarkers, cerebrospinal fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 12 May 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 combined measurement of Ab42 and tau protein (total and phosphorylated) in the spinal fluid has been shown to be promising in the diagnosis of Alzheimer's disease (AD), and has justified its inclusion new diagnostic criteria. However, it can sometimes yield discordant results that are not discriminant (isolated variation in Ab42 or P-181 Tau). To answer this challenge, a new marker has been developed in recent years, namely amyloid beta-peptide 1-40 (Aβ40). This marker reflects the patient's total amyloid deposits and is used to calculate the Aβ42/Aβ40 ratio. This ratio measures the relative variation of Aβ42 as compared to the total amyloid burden. Literature data on this topic are sparse and to date, no report has been published evaluating the utility of this marker in the diagnostic strategy for AD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD Patients | Experimental | Biological: spinal fluid collection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients attending the Memory Clinic of Champagne-Ardennes for memory disorders, and
- Whose diagnostic work-up requires assessment of biomarkers present in the cerebrospinal fluid are considered eligible for inclusion in this study.
Key exclusion criteria (1 listed)
- Patients who do not have any social security coverage will not be included.
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 |
|---|---|---|
| spinal fluid collection | Biological | AD Patients |
Primary outcome
Percentage of diagnostic certitude for AD (diagnosed cases)
Time frame: six months
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 21 Jan 2026.
- Background: PubMed 28745649Kisserli A, Tabary T, Cohen JHM, Duret V, Mahmoudi R. High-resolution Melting PCR for Complement Receptor 1 Length Polymorphism Genotyping: An Innovative Tool for Alzheimer's Disease Gene Susceptibility Assessment. J Vis Exp. 2017 Jul 18;(125):56012. doi: 10.3791/56012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal fluid collection in people with Alzheimer Disease, run by CHU de Reims 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 2 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: finished, as of the sponsor's last update on 21 Jan 2026. 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?
Percentage of diagnostic certitude for AD (diagnosed cases) (time frame: six months). 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 NCT02770482, which also lists 1 linked publication.
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 21 Jan 2026.