NCT01315717

Brief Summary

The purpose of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
912

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

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

Study Start

First participant enrolled

November 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 22, 2016

Status Verified

March 1, 2011

Enrollment Period

6.5 years

First QC Date

March 10, 2011

Last Update Submit

September 21, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stride-to-stride variability of stride time

    baseline

Study Arms (4)

Group 1

Healthy subjects

Group 2

Patients with Mild Cognitive Impairment

Group 3

Patients with Mild AD

Group 4

Patients with Moderate AD

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients of the University Memory Center of Angers Hospital with respect to the eligibility criteria.

You may qualify if:

  • Age ≥ 60 years
  • Able to walk without walking aid on 15 metres
  • Score of Mini-Mental Examination (MMSE) \> 10
  • Written informed consent to participate in the study (or trustworthy person)
  • Being affiliated to a social security regime
  • Near visual acuity ≥ 2/10
  • Absence of severe depression (score in the 15-item Geriatric Depression Scale ≤ 10)

You may not qualify if:

  • Score of Mini-Mental Examination (MMSE) ≤ 10
  • Subject suffering from pre-existing impellent disturbances
  • History of cerebrovascular accident or other cerebro-spinal pathology
  • Poor workmanship of the written or oral French language
  • Refusal of subject to be informed on possible hanging bare anomaly during study
  • Use of walking aid
  • Acute medical or surgical disease in the past 3 months
  • Refusal to participate (or trustworthy person)
  • Contra-indication to the achievement of a Magnetic Resonance Imaging
  • Near visual acuity \< 2/10
  • Presence of severe depression (score in the 15-item Geriatric Depression Scale \> 10)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers University Hospital

Angers, 49933, France

Location

Related Publications (1)

  • Graffe A, Beauchet O, Fantino B, Milea D, Annweiler C. Vitamin D and macular thickness in the elderly: an optical coherence tomography study. Invest Ophthalmol Vis Sci. 2014 Jul 15;55(8):5298-303. doi: 10.1167/iovs.14-13918.

MeSH Terms

Conditions

Gait ApraxiaAlzheimer DiseaseCognition Disorders

Condition Hierarchy (Ancestors)

Gait Disorders, NeurologicNeurologic ManifestationsNervous System DiseasesApraxiasPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Olivier Beauchet, MD, PhD

    Angers University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 15, 2011

Study Start

November 1, 2009

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 22, 2016

Record last verified: 2011-03

Locations