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Use of Saliva for Alzheimer's Disease Diagnosis (SalivALZ)

Primary Purpose

Alzheimer's Disease, Mild Cognitive Impairment

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Saliva samples
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer's Disease focused on measuring Alzheimer's disease, Mild Cognitive Impairment, Saliva, Amyloid peptides, Diagnosis

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)
    • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • CHRU

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with Alzheimer disease

Arm Description

Saliva samples were collected on this patients

Outcomes

Primary Outcome Measures

Aβ40 and Aβ42
Amyloid quantification using ultra sensitive immunoassays

Secondary Outcome Measures

Neuropsychologic tests
Neuropsychologic questionaries assessed on the Alzheimer patients
ApoE polymorphism
Measure of the ApoE polymorphism by biological analyses

Full Information

First Posted
July 27, 2016
Last Updated
December 27, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02864303
Brief Title
Use of Saliva for Alzheimer's Disease Diagnosis
Acronym
SalivALZ
Official Title
Predictive Value of the Aβ Peptides Salivary Dosage for Alzheimer's Disease Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
end of the inclusion period
Study Start Date
June 21, 2012 (Actual)
Primary Completion Date
October 11, 2018 (Actual)
Study Completion Date
October 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Mild Cognitive Impairment
Keywords
Alzheimer's disease, Mild Cognitive Impairment, Saliva, Amyloid peptides, Diagnosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Alzheimer disease
Arm Type
Other
Arm Description
Saliva samples were collected on this patients
Intervention Type
Other
Intervention Name(s)
Saliva samples
Intervention Description
saliva specimens were collected using a neutral or citric acid impregnated Salivette cotton swabs on Alzheimer patients to quantify the level of amyloid peptides
Primary Outcome Measure Information:
Title
Aβ40 and Aβ42
Description
Amyloid quantification using ultra sensitive immunoassays
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Neuropsychologic tests
Description
Neuropsychologic questionaries assessed on the Alzheimer patients
Time Frame
24 months
Title
ApoE polymorphism
Description
Measure of the ApoE polymorphism by biological analyses
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvain Lehmann, MD PhD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Saliva for Alzheimer's Disease Diagnosis

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