Effects of Transcranial Magnetic Stimulation (TMS) and Cognitive Training for Alzheimer Patients

NCT ID: NCT00909285

Last Updated: 2010-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-07-31

Brief Summary

Current diagnosis of Alzheimer disease is made by clinical, neuropsychological, and neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific features, such as atrophy, which is a late feature in the progression of the disease. Therefore, developing new approaches for early and specific recognition of Alzheimer disease at the prodromal stages is of crucial importance.

In the present study the investigators would like 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 Alzheimer's disease (AD) patients. A number of in vivo neuroimaging techniques, which can be used to reliably and noninvasively assess aspects of neuroanatomy, chemistry, physiology, and pathology, hold promise.

Conditions

Alzheimer Disease, Early Onset

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment Group (#1)

Group Type: EXPERIMENTAL

TMS stimulation

Intervention Type: DEVICE

TMS stimulation and cognitive training

Cognitive training

Intervention Type: BEHAVIORAL

TMS stimulation and cognitive training

Control group (#2)

Group Type: SHAM_COMPARATOR

Sham comparator

Intervention Type: DEVICE

Sham comparator

Interventions

TMS stimulation

TMS stimulation and cognitive training

Intervention Type: DEVICE

Sham comparator

Sham comparator

Intervention Type: DEVICE

Cognitive training

TMS stimulation and cognitive training

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 15 to 26
• 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 (transportation for the patient to and from the investigator's clinic, answering questions regarding the patient's condition and assuming responsibility for medication)
• Written informed consent by patient or legally responsible caregiver.
• Able to undergo MRI scanning sessions (e.g., prior to the onset of the study, upon the attainment of the primary end-point and at the end of the study).
• Commitment to participation in six-to eighteen weeks of the trial regimen consisting of approximately1 hour TMS stimulation and cognitive training daily treatment of five days a week - six to eighteen weeks (and up to two treatments a day in case the Third TMS stimulation and cognitive training Treatment protocol if necessary).

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;
• Clinically significant abnormal laboratory findings which have not been approved by the Project Director;

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assaf Harofeh Medical center

Principal Investigators

Shai Efrati, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh MC

Locations

Assaf-Harofeh MC

Beer-Yaakov, , Israel

Countries

Israel

Other Identifiers

NRX -NC-01

Identifier Type: -

Identifier Source: org_study_id