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

Alzheimer Disease, Early Onset Clinical Trial

Official title:

Testing the Effects of TMS Stimulation and Cognitive Training for Alzheimer Patients: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909285
• Other study ID #: NRX -NC-01
• Status: Completed
• Phase: N/A
• First received: May 24, 2009
• Last updated: July 11, 2010
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset

Intervention

Device:
• TMS stimulation
TMS stimulation and cognitive training
• Sham comparator
Sham comparator

Behavioral:
• Cognitive training
TMS stimulation and cognitive training

Locations

Country	Name	City	State
Israel	Assaf-Harofeh MC	Beer-Yaakov

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the efficacy of the TMS stimulation with cognitive training in treatment of early- to mid- stage Alzheimer's patients will be established by improvement of at least 4 points on ADAS-COG.		3 months	No
Secondary	Safety will be established by paucity of related adverse events.		3 months	Yes