TMS Stimulation and Cognitive Training in Alzheimer Patients

Phase 1

Completed

• Conditions: Alzheimer Disease; Mild to Moderate
• Interventions: Device: NICE-System; Device: Sham-NICE-System

• Registration Number: NCT01168245
• Lead Sponsor: Neuronix Ltd

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-23
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-26
• Last Update Posted: 2013-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NICE-System NeuroAD	NICE-System	Treatment Group
Sham-TMS	Sham-NICE-System	Control Group

Primary Outcome Measures

Name	Time	Method
A significant improvement and/or improvement of at least 2 points on ADAS-COG of the Treatment Group in comparison with the Placebo Group after 6 weeks of treatment.	pre-treatment, 6, and 18 weeks

Secondary Outcome Measures

Name	Time	Method
Safety profile: rate of device and/or procedure related adverse events.	weekly

Trial Locations

Locations (1)

Assaf-Harofeh Medical Center; 🇮🇱 Beer Yaakov, Israel