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Completed

NCT Number: NCT01825317

Effect of NeuroAD on Alzheimer Patients

Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer for the treatment of Alzheimer patients.

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chungnam national university hospital, Daejeon Geriatric Medical Center

Daejeon, South Korea

About this study

Synchronized TMS and cognitive training for the treatment of mild to moderate Alzheimer's patients. Treatment is delivered 5 days a week, for 6 weeks, visit is about an hour long.

Evaluation is by neuropsychological evaluation at 6 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female age 60-90 years
  • Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the DSM-IV criteria.
  • MMSE score 18 to 26
  • Adas-cog above 17
  • Physically acceptable for the study as confirmed by medical history and exam.
  • Spouse, family member or professional caregiver agree and capable of taking care and be responsible for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
  • Agreement to participate in approximately 14 weeks during the study.
  • Normal or corrected to normal ability to see and to hear.
  • Korean as primary language
  • 8th grade education minimum

Exclusion criteria

  • CDR 0 or 3
  • Severe agitation;
  • Mental retardation;
  • Patient lacking capacity to consent to study participation
  • Unstable medical condition;
  • Use of benzodiazepines or barbiturates 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;
  • History of Epileptic Seizures or Epilepsy;
  • Contraindication for performing MRI scanning;
  • Contraindication for receiving TMS treatment according to a TMS questionnaire;
  • Pregnant women, and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
  • Patients with personal history of any clinically defined neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, or multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness.
  • Patients with depression, bipolar disorder or psychotic disorders or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study
  • Alcoholism or drug addiction as defined by DSM-IV within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
  • Patients treated with cholinesterase inhibitors, or memantine or Ginko-biloba will be allowed to participate, if the treatment has started at least 6 months previous to recruitment. The patients should keep their dose of medication during the whole trial as prior to study begin.
  • Patients with metal in the head, except the mouth (i.e. cochlear implants, implanted brain stimulators, aneurysm clips)
  • Patients with increased intracranial pressure
  • Cardiac pacemakers
  • Implanted neurostimulators
  • Implanted medication pumps
  • Intracardiac lines
  • Significant heart disease
  • Currently taking medication that lower the seizure threshold
  • Significant sleep deprivation and alcoholism

Treatment and study plan

NeuroAD

Device

synchronized TMS+COGNITIVE TRAINING

Other names: NICE

Sham device

Device

Sham TMS+cog, has the same sound and appearance as the real device, delivers no energy.

Other names: Control device

Primary outcomes

  1. ADAS-Cog

    Time frame: 6 weeks

    Alzheimer's disease assessment scale - cognitive test

Sponsors and collaborators

Lead sponsor

Neuronix Ltd

Industry

Collaborators

  • Chungnam National University Hospital
  • company: K The Power

Registry information

Official study title

Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2013
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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