NCT06501495

Brief Summary

With age, memory processes (encoding, consolidation and retrieval) as well as daytime vigilance are altered. Sleep is also impaired in older adults, notably slow waves that are known to play a key role in memory consolidation. Interestingly, some slow waves can also be detected in EEG recordings during wakefulness, and have been related to vigilance fluctuations. The investigators believe that slow waves, during both sleep and wakefulness, could constitute a common biomarker of sleep disturbances and daytime vigilance problems. A dysregulation of slow waves could thus explain the impact of aging on the different memory processes. Since alterations in memory capacity, attention, and sleep quality are further exacerbated in patients with Alzheimer's disease (AD), the investigators propose to study the links between aging (normal and pathological), sleep and daytime vigilance alterations, and their impacts on the different key stages of memory. The investigators will examine the associations between slow waves and changes in memory and vigilance in normal and pathological aging by studying young adults, seniors without cognitive disorders, and patients with prodromal AD. By replaying sensory cues associated with learning material during sleep, the investigators will also evaluate the effectiveness of auditory stimulation during sleep to enhance memory consolidation in older adults without and without cognitive deficits. Overall, this study aims to better understand the relationships between slow waves, aging, memory, and vigilance, providing insights into cognitive decline and potential interventions in aging and Alzheimer's disease.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress54%
Apr 2025Apr 2027

First Submitted

Initial submission to the registry

July 1, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

April 24, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

July 1, 2024

Last Update Submit

April 8, 2026

Conditions

Keywords

agingAlzheimer's diseasesleepmemoryattentionslow

Outcome Measures

Primary Outcomes (1)

  • slow waves density

    quantifying slow waves with their density (during sleep, wakefulness at rest and during tasks)

    2 days

Study Arms (1)

young adults, older adults without cognitive deficits, prodromal Alzheimer's Disease

EXPERIMENTAL

young adults, older adults without cognitive deficits, prodromal Alzheimer's Disease

Other: video polysomnographyOther: Attention task

Interventions

video polysomnography during 2 nights

young adults, older adults without cognitive deficits, prodromal Alzheimer's Disease

Attention task : SART Test (Sustained Attention to Response Task)

young adults, older adults without cognitive deficits, prodromal Alzheimer's Disease

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female Signed informed consent Affiliated with a social security system Native French speakers Completed at least 7 years of schooling (minimum 9th grade level)
  • Patients:
  • Age: 60 to 85 years Prodromal stage of Alzheimer's disease diagnosed according to international diagnostic criteria, characterized by a clinical phenotype of progressive amnesic syndrome of the hippocampal type, associated with biological markers of Alzheimer's disease 1) from lumbar puncture (Aβ \< 600 pg/mL and ptau \> 60 pg/mL)or 2) amyloid PET (positron emission tomography), or 3) with positive plasma Alzheimer's biomarkers
  • Cognitively Healthy Seniors:
  • Age: 60 to 85 years Age and sex matched with the Patients group "Cognitively healthy" status defined by a score of ≥ 26 on the MMSE (Mini-Mental State Examination), a score of ≥ 16 on the BREF (Batterie Rapide d'Efficience Frontale), and a score of ≥ 8 on the 5-word test
  • Young Adults:
  • Age: 18 to 35 years Sex matched with the Patients group "Cognitively healthy" status defined by a score of ≥ 26 on the MMSE (Mini-Mental State Examination), a score of ≥ 16 on the BREF (Batterie Rapide d'Efficience Frontale), and a score of ≥ 8 on the 5-word test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maladies du Sommeil

Paris, 75013, France

RECRUITING

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Marc Teichmann, MD

    assisitance publique Hôpitaux de paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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 1, 2024

First Posted

July 15, 2024

Study Start

April 24, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations