Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease - Full Text View

Sponsored by:	Tel-Aviv Sourasky Medical Center
Information provided by:	Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT00743418

Purpose

The research is aimed at exploring the application of novel tracking technique for the study of spatial activity among dementia patients and its implication on their families. The study sample will be composed of three groups of volunteers, each including100 participants aged over 60 years. The first group will include MCI (Mild Cognitive Impairment) patients. The second group will include patients that suffer from mild dementia. The third group will include age matched healthy participants. The tracking equipment will be a GPS apparatus of 450 gms that will be carried by the participants for 24 hours along 2-4 weeks. The GPS data will be transferred via the cellular network to operator center at the Hebrew university at Jerusalem, and will be documented in assigned data files. This monitoring procedure will be held every year and along a period of five years. The impact of the patient behavior on the care giver will be studied by means of five interviews along the tracking period.

Condition	Intervention	Phase
Dementia	Device: GPS modem and RFID	Phase I Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Non-Randomized, Open Label, Parallel Assignment
Official Title:	The Use of Advanced Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease and Related Cognitive Disorders

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

Evaluation tools include: Geriatric Depression Scale, functional health questionnaire (SF-36), Emotional well-being questionnaire (Positive and Negative Affect Schedule; PANAS), single Life Satisfaction question and the Zarit Burden Interview [ Time Frame: Before and after interventions ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	June 2007
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Healthy controls Mini Mental State evaluation score >28/30	Device: GPS modem and RFID The participant will take the GPS kit with him/her everywhere during the whole day for a period of 4 weeks. The GPS tracking kit consists of a GPS receiver with a GSM modem, an RF transmitter contained in a wrist-watch and a monitoring unit located in the home that enables researchers to know whenever the tracked person leaves home. The waterproof RF transmitter will allow researchers to know whether or not research subjects leave home with the GPS device and if they are carrying the device or not at a given moment.
2 Mild Cognitive Impairment: Mini Mental State Evaluation Score (MMSE)=26-28/30	Device: GPS modem and RFID The participant will take the GPS kit with him/her everywhere during the whole day for a period of 4 weeks. The GPS tracking kit consists of a GPS receiver with a GSM modem, an RF transmitter contained in a wrist-watch and a monitoring unit located in the home that enables researchers to know whenever the tracked person leaves home. The waterproof RF transmitter will allow researchers to know whether or not research subjects leave home with the GPS device and if they are carrying the device or not at a given moment.
3 Mild Dementia: Mini Mental State Evaluation Score (MMSE)=21-25/30	Device: GPS modem and RFID The participant will take the GPS kit with him/her everywhere during the whole day for a period of 4 weeks. The GPS tracking kit consists of a GPS receiver with a GSM modem, an RF transmitter contained in a wrist-watch and a monitoring unit located in the home that enables researchers to know whenever the tracked person leaves home. The waterproof RF transmitter will allow researchers to know whether or not research subjects leave home with the GPS device and if they are carrying the device or not at a given moment.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients with MCI, Alzheimer's disease, or mixed type dementia; OR
Healthy control subjects who meet the following criteria:
- Mini Mental State (MMSE) of at least 21
- Age 60 years or older
- Patients with history of stroke which is not followed by cognitive decline may be included
- Fluent language skills

Exclusion Criteria:

Other dementias (e.g. vascular, frontotemporal, metabolic etc);
Other major psychiatric disorders (e.g. major depression, schizophrenia);
Substance abuse;
MMSE 20 or less;
Severe motor disturbances;
Sensory deficits potentially affecting mobility; OR
Severe physical disorders (e.g. cancer, major operation)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743418

Contacts

Contact: Jeremia Heinik, MD

972-3-6974817

jeremiah@tasmc.health.gov.il

Locations

Israel
Psychogeriatric clinic, Sourasky Medical Center	Recruiting
Tel-Aviv, Israel, 64239
Contact: Jeremia Heinik, MD 972-3-6974817 jeremiah@tasmc.health.gov.il
Principal Investigator: Jeremia Heinik, MD

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

More Information

SenTra Website This link exits the ClinicalTrials.gov site

Publications:

Shoval N, Auslander GK, Freytag T, Landau R, Oswald F, Seidl U, Wahl HW, Werner S, Heinik J. The use of advanced tracking technologies for the analysis of mobility in Alzheimer's disease and related cognitive diseases. BMC Geriatr. 2008 Mar 26;8:7.

Responsible Party:	Psychogeriatric clinic, Sourasky Medical Center, Tel-Aviv Israel ( Dr' Jeremia Heinik )
Study ID Numbers:	DIP-K.3.1.
Study First Received:	August 27, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00743418
Health Authority:	Israel: The Israel National Institute for Health Policy Research and Health Services Research

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009