NCT01692977

Brief Summary

The disruption of spatial orientation is considered the second most common cognitive symptom of dementia, affecting nearly all activities of daily living. Research in the field of environmental psychology has helped to highlight the influence of the environment on patients with Alzheimer's disease or related syndromes. With regard to spatial orientation, it has been shown that an environment can provide support for cognitive failures in subjects if that particular space is adapted. While numerous studies have focused on the architectural environment (hospital, housing facility), none have explored the ability of patients to orient themselves in a natural environment such as a garden. Yet, in recent years, such gardens, known as healing gardens, have emerged in housing and care facilities, providing genuine support for the care management of patients with Alzheimer-type dementia. Various works have been published outlining recommendations for their management. However, with regard to spatial orientation, none of the available research has explored the basic principles on which to rely on in order to organize the elements of outdoor spaces into itineraries that promote orientation, according to ZEISEL and TYSON (1999). In the absence of such data, these authors recommend relying on five elements, identified by Lynch in his landmark book "Image of the City" (1960), that people use to orient themselves and find their way. These are " paths ", " edges ", " districts ", " nodes " and " landmarks ". The hypothesis to verify is that patients with Alzheimer's disease do not rely on the same elements of the garden as non-Alzheimer's subjects in making orientation decisions and to mentally picture this environment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Aug 2012

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

August 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

August 16, 2012

Last Update Submit

July 29, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analyze nature and frequency of elements of the " art, memory and life " garden used as landmarks by Alzheimer's disease patients

    To describe and compare nature and frequency of elements involved in orientation decisions and the cognitive map, between a group of subjects with Alzheimer's disease and a group of healthy control subjects.

    Baseline = inclusion visit

Secondary Outcomes (2)

  • Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.

    Baseline = inclusion visit

  • Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.

    Baseline = inclusion visit

Study Arms (2)

Alzheimer disease patients

EXPERIMENTAL

Alzheimer disease patients

Other: neuropsychological assessment

control

ACTIVE COMPARATOR

healthy control subjects.

Other: neuropsychological assessment

Interventions

Alzheimer disease patientscontrol

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • All subjects (groups A and B):
  • able to walk autonomously, that is without help, whether human or technical, except for a walking cane
  • are aged 65 to 90 years
  • have never been in the "art, memory and life" garden at the Paul SPILLMANN Centre prior to the study
  • have given their written consent after receiving clear and intelligible oral and written information.
  • Group A : patients with Alzheimer's disease:
  • diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA diagnostic criteria (Mc KHANN et al., 1984)
  • score less than or equal to 4 on the Hachinski ischemic scale (Hachinski et al., 1984)
  • Folstein MMSE score between 10 and 24 inclusively
  • score equal to 5 or 6 on the Reisberg Global Deterioration Scale (REISBERG et al., 1982).
  • stable, specific treatment of Alzheimer's disease (cholinesterase and memantine)
  • taking of psychotropic drugs authorized, but no change in treatment during at least the last 48 hours
  • Group B: healthy control subjects:
  • absence of dementia according to NINCDS-ADRDA criteria (Mc KHANN et al., 1984)
  • normal performance on Folstein MMSE, according to the GRECO (en français : Groupe de REflexions sur les Evaluations Cognitives) standards (Reflection Group on Cognitive Assessments)

You may not qualify if:

  • For all subjects (groups A and B):
  • Absence of social security coverage
  • sensory deficit interfering with the task
  • aphasia interfering with the task
  • history of head trauma (with loss of consciousness)
  • chronic alcoholism
  • refusal or inability to obtain written informed consent form from the patient
  • legally protected person
  • severe depression: score higher than 20 on the 30-item Geriatric Depression Scale (GDS)
  • Group A : patients with Alzheimer's disease:
  • other neurological or psychiatric diseases that may affect the assessment Group B: healthy control subjects
  • neurological or psychiatric diseases that may affect the assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Nancy , Saint Julien Hospital, France

Nancy, 54000, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Thérèse Rivasseau Jonveaux, PhD

    University Hospital of Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 16, 2012

First Posted

September 26, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations