NCT01315704

Brief Summary

The purpose of this study is to compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to establish a database at Angers University Memory Centre.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

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
unknown

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 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 15, 2011

Status Verified

March 1, 2011

Enrollment Period

8 years

First QC Date

March 11, 2011

Last Update Submit

March 14, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Spatiotemporal gait parameters

    baseline

Study Arms (3)

Group 1

Patients with Mild Cognitive Impairment

Drug: Drug intervention

Group 2

Patients with Mild Alzheimer's disease or related disorders

Drug: Drug intervention

Group 3

Patients with Moderate Alzheimer's disease or related disorders

Drug: Drug intervention

Interventions

before-after interventional (anti-dementia drugs and/or vitamin D) study

Also known as: Anti-dementia drugs and/or vitamin D
Group 1Group 2Group 3

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • All elderly patients from the University Memory Center of Angers University Hospital.
  • Able to walk without any walking aid on 15 meters
  • Mini-Mental Status Examination score \> 10
  • Being affiliated to a social security regime

You may not qualify if:

  • Mini-Mental Status Examination score ≤ 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
  • Use of walking aid such as walking frame with wheels or tricycle.
  • Acute medical or surgical disease in the past 3 months
  • Refusal to participate (or trustworthy person)
  • Near visual acuity \< 2/10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cédric ANNWEILER , MD

Angers, 49933, France

RECRUITING

Related Publications (2)

  • Beauchet O, Barden J, Liu-Ambrose T, Chester VL, Annweiler C, Szturm T, Grenier S, Leonard G, Bherer L, Allali G; Canadian Gait Consortium. Anti-Dementia Drugs, Gait Performance and Mental Imagery of Gait: A Non-Randomized Open-Label Trial. Drugs Aging. 2016 Sep;33(9):665-73. doi: 10.1007/s40266-016-0391-0.

  • Beauchet O, Launay CP, Allali G, Watfa G, Gallouj K, Herrmann FR, Annweiler C. Anti-dementia drugs and changes in gait: a pre-post quasi-experimental pilot study. BMC Neurol. 2013 Nov 21;13:184. doi: 10.1186/1471-2377-13-184.

MeSH Terms

Conditions

Alzheimer DiseaseGait ApraxiaCognition Disorders

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersGait Disorders, NeurologicNeurologic ManifestationsApraxiasPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cedric ANNWEILER, MD

    Memory Centre of Angers University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cedric ANNWEILER, DM

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 15, 2011

Study Start

November 1, 2009

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

March 15, 2011

Record last verified: 2011-03

Locations