Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease (SenTra)

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Dementia

Treatments: Device: GPS modem and RFID

Study type: Interventional

Funder types: Other

Identifiers

NCT00743418

DIP-K.3.1.

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

1

Other group

Description:

Healthy controls Mini Mental State evaluation score \>28/30

Treatment:

Device: GPS modem and RFID

2

Other group

Description:

Mild Cognitive Impairment: Mini Mental State Evaluation Score (MMSE)=26-28/30

Treatment:

Device: GPS modem and RFID

3

Other group

Description:

Mild Dementia: Mini Mental State Evaluation Score (MMSE)=21-25/30

Treatment:

Device: GPS modem and RFID