NCT02864303

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2012

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2018

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

6.3 years

First QC Date

July 27, 2016

Last Update Submit

December 27, 2021

Conditions

Alzheimer's DiseaseMild Cognitive Impairment

Keywords

Alzheimer's diseaseMild Cognitive ImpairmentSalivaAmyloid peptidesDiagnosis

Outcome Measures

Primary Outcomes (1)

  • Aβ40 and Aβ42

    Amyloid quantification using ultra sensitive immunoassays

    24 months

Secondary Outcomes (2)

  • Neuropsychologic tests

    24 months

  • ApoE polymorphism

    24 months

Study Arms (1)

Patients with Alzheimer disease

OTHER

Saliva samples were collected on this patients

Other: Saliva samples

Interventions

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

Patients with Alzheimer disease

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 ;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionDisease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sylvain Lehmann, MD PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 12, 2016

Study Start

June 21, 2012

Primary Completion

October 11, 2018

Study Completion

October 11, 2018

Last Updated

December 28, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)