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

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.

Study Overview

• Status: Terminated
• Conditions: Mild Cognitive Impairment; Alzheimer's Disease
• Intervention / Treatment: Other: Saliva samples

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with Alzheimer disease; Saliva samples were collected on this patients	Other: Saliva samples; saliva specimens were collected using a neutral or citric acid impregnated Salivette cotton swabs on Alzheimer patients to quantify the level of amyloid peptides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aβ40 and Aβ42	Amyloid quantification using ultra sensitive immunoassays	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychologic tests	Neuropsychologic questionaries assessed on the Alzheimer patients	24 months
ApoE polymorphism	Measure of the ApoE polymorphism by biological analyses	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Sylvain Lehmann, MD PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2012
• Primary Completion (Actual): October 11, 2018
• Study Completion (Actual): October 11, 2018

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 27, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Mild Cognitive Impairment; Diagnosis; Saliva; Amyloid peptides
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 8835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No