NCT01168245

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at P25-P50 for phase_1 alzheimer-disease

Timeline
Completed

Started Jan 2010

Typical duration for phase_1 alzheimer-disease

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

January 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

March 28, 2013

Status Verified

March 1, 2013

Enrollment Period

1.7 years

First QC Date

July 22, 2010

Last Update Submit

March 26, 2013

Conditions

Alzheimer DiseaseMild to Moderate

Keywords

Alzheimer DiseaseDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseaseCognitive TrainingCortical ReorganizationBrain Plasticity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Safety profile: rate of device and/or procedure related adverse events.

    weekly

Study Arms (2)

NICE-System NeuroAD

EXPERIMENTAL

Treatment Group

Device: NICE-System

Sham-TMS

SHAM COMPARATOR

Control Group

Device: Sham-NICE-System

Interventions

Sham-NICE-SystemDEVICE

sham TMS and sham cognitive training

Also known as: NICE-System
Sham-TMS
NICE-SystemDEVICE

TMS combined with cognitive training

NICE-System NeuroAD

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-Harofeh Medical Center

Beer Yaakov, 70300, Israel

Location

Related Publications (1)

  • Rabey JM, Dobronevsky E, Aichenbaum S, Gonen O, Marton RG, Khaigrekht M. Repetitive transcranial magnetic stimulation combined with cognitive training is a safe and effective modality for the treatment of Alzheimer's disease: a randomized, double-blind study. J Neural Transm (Vienna). 2013 May;120(5):813-9. doi: 10.1007/s00702-012-0902-z. Epub 2012 Oct 18.

    PMID: 23076723RESULT

MeSH Terms

Conditions

Alzheimer DiseaseDementiaBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Condition Hierarchy (Ancestors)

TauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Martin Rabey, Prof.

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 23, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 28, 2013

Record last verified: 2013-03

Locations

IL(1)