Assessment of Sleep Disturbance in Alzheimer Disease

Alzheimer Disease Clinical Trial

Official title:

Assessment of Sleep Disturbance in Alzheimer Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831298
• Other study ID #: 08-PP-07
• Status: Completed
• Phase: N/A
• First received: January 27, 2009
• Last updated: December 8, 2011
• Start date: July 2010
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• alzheimer disease

• MMSE > 20

• over 65 years old

Exclusion Criteria:

• new psychotropic drug treatment

• patient unable to do neuropsychologic tests

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Dyssomnias
• Parasomnias
• Sleep Disorders

Intervention

Other:
• Analysis of sleep disturbance
Behavioral Questionnaire Sleep Recordings Genetic analysis

Locations

Country	Name	City	State
France	Centre Mémoire de Ressources et de Recherche, CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of apathy		at day 0, just after inclusion	No
Secondary	assessment of sleep disturbance		during a week, between day 0 and day 7	No
Secondary	determine a genetic relationship between sleep disturbance and alzheimer disease		after all genetic analyses of the study	No