Alzheimer's DiseaseSalivALZNCT02864303
Use of Saliva for Alzheimer's Disease Diagnosis
A study testing Saliva samples in people with Alzheimer's Disease and Mild Cognitive Impairment, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Although saliva is not generally regarded as one of the most interesting biological fluids, the fact that it can be sampled using simple, noninvasive methods makes it an interesting alternative to cerebrospinal fluid (CSF) or blood for diagnostic purposes. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- Saliva samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2012to 11 Oct 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men/Women;
- Aged ≥ 55 years and 80 years;
- Patients mild cognitive impairment (MCI), not answering either the criteria of a normal cognitive functioning or the criteria of the insanity, but meeting the criteria of diagnosis of following MCI in the term of a complete cognitive balance sheet (assessment) and according to the diagnostic procedure published by the work group on the MCI of the EADC:
- Mnesic complaint
- Decline of the cognitive performances with regard to the previous capacities
- Cognitive disorders(confusions) objectified by the clinical evaluation (change of the memory and/or another cognitive sphere)
Show all 10Show fewer
- The cognitive change has no echo on the everyday life
- Not dementia syndrome
- Signature of the informed consent by the patient;
- Subject affiliated to a national insurance scheme.
Who cannot join
- Edentulous total or poor oral hygiene;
- Absence of the signed informed consent;
- Clinical and laboratory information insufficient or unavailable;
- Patient deprived of freedom, by court or administrative order;
- Major protected by law;
- Presence of a contagious viral affection (HIV, hepatitis B and C);
- Patient included in a therapeutic trial targeting the metabolism of metabolism of amyloid peptides ;
- Patient in period of relative exclusion with regard to another protocol or for which the annual maximum amount of the 4500-compensations was reached.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of the Aβ Peptides Salivary Dosage for Alzheimer's Disease Diagnosis
Although saliva is not generally regarded as one of the most interesting biological fluids, the fact that it can be sampled using simple, noninvasive methods makes it an interesting alternative to cerebrospinal fluid (CSF) or blood for diagnostic purposes. The use of salivary diagnostics is moreover increasing these past 10 years, as shown with the abundant literature as well as various clinical trials. Saliva collection which is now well standardized has the major advantage of being simple and non-invasive. An original study had already discussed possible changes in the salivary composition in Alzheimer's disease (AD). The feasibility and the potential interest of measuring saliva concentration of the amyloid peptides was reported in an article published recently. The prospect of using saliva for early diagnosis and monitoring of AD is thus of major interest and the objective of the current trial.
Read the detailed description
Saliva samples
To minimize the circadian effects, saliva specimens were all collected between 9:00 and 11:00 a.m. Prior to the sampling procedure, participants rinsed out their mouths three times with water. To induce salivary production, patients were asked to chew neutral or citric acid impregnated Salivette cotton swabs for exactly 60 seconds. Saliva specimens were centrifuged for 2 minutes at a rate of 1000 g to yield clear saliva, which was aliquoted into 500 µL samples in LoBind tubes and stored at -80°C before being analyzed.
Design of the study
Saliva sampling will be performed at V0 (M0), V1 (M12) and V2 (M24). Blood sampling will take place also in V1 (M12). The cases and the controls will be systematically reviewed 12 months after inclusion with a new saliva collection and a cognitive assessment (for cases and controls).
Amyloid peptide quantification
Levels of human endogenous Aβ40 and Aβ42 in saliva and human plasma samples are determined with human specific enzyme-linked immunosorbent assay (ELISA) (Biosource International, Invitrogen), according to the manufacturer's instructions. Briefly, 50 μl of saliva and plasma samples were added in triplicate to the microtiter wells. Detection limit of the assay was 6 pg/ml for Aβ40 and 1 pg/ml for Aβ42.
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Being tested
- Saliva samples
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment, Saliva, Amyloid peptides, Diagnosis
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva samplesOther
saliva specimens were collected using a neutral or citric acid impregnated Salivette cotton swabs on Alzheimer patients to quantify the level of amyloid peptides
| Study group | Role | What they receive |
|---|---|---|
| Patients with Alzheimer disease | Other | Saliva samples were collected on this patients Receives: Other: Saliva samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aβ40 and Aβ42
Amyloid quantification using ultra sensitive immunoassays
Measured: 24 months
Secondary outcomes (2)
Neuropsychologic tests
Neuropsychologic questionaries assessed on the Alzheimer patients
Measured: 24 months
ApoE polymorphism
Measure of the ApoE polymorphism by biological analyses
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start21 Jun 2012
- Primary completion11 Oct 2018
- Study completion11 Oct 2018
Why it stopped: end of the inclusion period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain Lehmann, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864303
- Sponsor's protocol ID
- 8835
- Acronym
- SalivALZ
- Status last verified
- Dec 2021
- First submitted
- 27 Jul 2016
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the Aβ Peptides Salivary Dosage for Alzheimer's Disease Diagnosis
- ClinicalTrials.gov ID
- NCT02864303
- Acronym / sponsor ID
- SalivALZ / 8835
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment, Saliva, Amyloid peptides, Diagnosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of the inclusion period
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 21 Jun 2012 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 12 Aug 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.
Although saliva is not generally regarded as one of the most interesting biological fluids, the fact that it can be sampled using simple, noninvasive methods makes it an interesting alternative to cerebrospinal fluid (CSF) or blood for diagnostic purposes. The use of salivary diagnostics is moreover increasing these past 10 years, as shown with the abundant literature as well as various clinical trials. Saliva collection which is now well standardized has the major advantage of being simple and non-invasive. An original study had already discussed possible changes in the salivary composition in Alzheimer's disease (AD). The feasibility and the potential interest of measuring saliva concentration of the amyloid peptides was reported in an article published recently. The prospect of using saliva for early diagnosis and monitoring of AD is thus of major interest and the objective of the current trial.
Detailed description
Saliva samples
To minimize the circadian effects, saliva specimens were all collected between 9:00 and 11:00 a.m. Prior to the sampling procedure, participants rinsed out their mouths three times with water. To induce salivary production, patients were asked to chew neutral or citric acid impregnated Salivette cotton swabs for exactly 60 seconds. Saliva specimens were centrifuged for 2 minutes at a rate of 1000 g to yield clear saliva, which was aliquoted into 500 µL samples in LoBind tubes and stored at -80°C before being analyzed.
Design of the study
Saliva sampling will be performed at V0 (M0), V1 (M12) and V2 (M24). Blood sampling will take place also in V1 (M12). The cases and the controls will be systematically reviewed 12 months after inclusion with a new saliva collection and a cognitive assessment (for cases and controls).
Amyloid peptide quantification
Levels of human endogenous Aβ40 and Aβ42 in saliva and human plasma samples are determined with human specific enzyme-linked immunosorbent assay (ELISA) (Biosource International, Invitrogen), according to the manufacturer's instructions. Briefly, 50 μl of saliva and plasma samples were added in triplicate to the microtiter wells. Detection limit of the assay was 6 pg/ml for Aβ40 and 1 pg/ml for Aβ42.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Alzheimer disease | Other | Other: Saliva samplesSaliva samples were collected on this patients |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men/Women;
- Aged ≥ 55 years and 80 years;
- Patients mild cognitive impairment (MCI), not answering either the criteria of a normal cognitive functioning or the criteria of the insanity, but meeting the criteria of diagnosis of following MCI in the term of a complete cognitive balance sheet (assessment) and according to the diagnostic procedure published by the work group on the MCI of the EADC:
- Signature of the informed consent by the patient;
- Subject affiliated to a national insurance scheme.
Key exclusion criteria (8 listed)
- Edentulous total or poor oral hygiene;
- Absence of the signed informed consent;
- Clinical and laboratory information insufficient or unavailable;
- Patient deprived of freedom, by court or administrative order;
- Major protected by law;
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 |
|---|---|---|
| Saliva samplessaliva specimens were collected using a neutral or citric acid impregnated Salivette cotton swabs on Alzheimer patients to quantify the level of amyloid peptides | Other | Patients with Alzheimer disease |
Primary outcome
Aβ40 and Aβ42
Time frame: 24 months
Amyloid quantification using ultra sensitive immunoassays
2 secondary outcomes
Neuropsychologic tests
Time frame: 24 months
ApoE polymorphism
Time frame: 24 months
Results and safety
The study was stopped early (reason given: end of the inclusion period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- 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.
Sylvain Lehmann, MD PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva samples in people with Alzheimer's Disease and Mild Cognitive Impairment, run by University Hospital, Montpellier 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 10 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Dec 2021. 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 was stopped early (reason given: end of the inclusion period). 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?
Aβ40 and Aβ42 (time frame: 24 months). 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 28 Dec 2021.