TMS Stimulation and Cognitive Training in Alzheimer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-09-30

Brief Summary

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The aim of this study is to examine if combined treatment with TMS and cognitive training (CoTra) for several weeks can produce a sustained improvement in cognitive and behavioral symptomatology of mild to moderate Alzheimer's disease (AD) patients.

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Detailed Description

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The current available pharmaceutical treatment for Alzheimer Disease (AD) is only partially and temporary effective. Therefore, new approaches are needed. rTMS is a non-invasive technique which generates a small electric current that induces a modulation in cortical excitability. In addition, cognitive training was suggested to improve cognitive functions in Alzheimer patients.

In this study we intend to treat mild to moderate AD patients with rTMS interlaced with cognitive training (rTMS- COG).

Patients with probable AD will be treated with rTMS-COG daily for 6 weeks followed by maintenance sessions for additional 3 months.

Conditions

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Alzheimer Disease Mild to Moderate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NICE-System NeuroAD

Treatment Group

Group Type EXPERIMENTAL

NICE-System

Intervention Type DEVICE

TMS combined with cognitive training

Sham-TMS

Control Group

Group Type SHAM_COMPARATOR

Sham-NICE-System

Intervention Type DEVICE

sham TMS and sham cognitive training

Interventions

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Sham-NICE-System

sham TMS and sham cognitive training

Intervention Type DEVICE

NICE-System

TMS combined with cognitive training

Intervention Type DEVICE

Other Intervention Names

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NICE-System

Eligibility Criteria

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Inclusion Criteria

* Male or female age 55-85 years
* Patients diagnosed with early or moderate stage of Alzheimer's disease, according to the DSM-IV criteria.
* MMSE score 18 to 24
* Global Dementia rating 1 or 2
* Physically acceptable for the study as confirmed by medical history and exam, clinical laboratory results and EKG
* Spouse, family member or professional caregiver agree and capable of taking care and responsibility for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
* Written informed consent by both patient and legally responsible caregiver.
* Able to undergo MRI scan and EEG recordings prior to the onset of the study.
* Agreement to participate in up to 9 months the study.
* Right handed
* Hebrew or Russian as mother tongue and/or ability to read and understand the inform consent form (ICF), and the Patient Information document in Hebrew or Russian.

Exclusion Criteria

* Severe agitation;
* Mental retardation;
* Unstable medical condition;
* Use of benzodiazepines or other hypnotics during the study and preceding two weeks;
* Pharmacological immunosuppression;
* Participation in a clinical trial with any investigational agent within two weeks prior to study enrollment;
* Alcoholism;
* History of Epileptic Seizures or Epilepsy;
* Contraindication for performing MRI scanning;
* Contraindication for receiving TMS treatment according to a TMS questionnaire;
* Clinically significant abnormal laboratory findings which have not been approved by the Principle Investigator;
* Patients treated with cholinesterase inhibitors, or memantine or ginko-biloba will be allowed to participate, if the treatment has started at least 2 months previous to recruited.

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No