NCT00831298

Brief Summary

The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates to changes in activity cycles, and how sleep disturbances may affect your daytime alertness. This project selects patients suffering from memory problems, or voluntary to be in our Control Group. There are three parts to this study: Sleep Diaries, Behavioral Questionnaire, and Activity Recordings

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

January 27, 2009

Last Update Submit

March 26, 2026

Conditions

Alzheimer Disease

Keywords

alzheimer diseasesleep disturbanceapathymemory loss

Outcome Measures

Primary Outcomes (1)

  • assessment of apathy

    at day 0, just after inclusion

Secondary Outcomes (2)

  • assessment of sleep disturbance

    during a week, between day 0 and day 7

  • determine a genetic relationship between sleep disturbance and alzheimer disease

    after all genetic analyses of the study

Study Arms (1)

1

OTHER

Behavioral Questionnaire Sleep Recordings Genetic analysis

Other: Analysis of sleep disturbance

Interventions

Analysis of sleep disturbanceOTHER

Behavioral Questionnaire Sleep Recordings Genetic analysis

1

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • alzheimer disease
  • MMSE \> 20
  • over 65 years old

You may not qualify if:

  • new psychotropic drug treatment
  • patient unable to do neuropsychologic tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Mémoire de Ressources et de Recherche, CHU de Nice

Nice, 06000, France

Location

Related Publications (1)

  • Ettore E, Bakardjian H, Sole M, Levy Nogueira M, Habert MO, Gabelle A, Dubois B, Robert P, David R. Relationships between objectives sleep parameters and brain amyloid load in subjects at risk for Alzheimer's disease: the INSIGHT-preAD Study. Sleep. 2019 Sep 6;42(9):zsz137. doi: 10.1093/sleep/zsz137.

    PMID: 31267124RESULT

MeSH Terms

Conditions

Alzheimer DiseaseParasomniasLethargyMemory Disorders

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSleep Wake DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philippe ROBERT

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

July 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)