Effect of NeuroAD on Alzheimer Patients

NCT01825317 | Completed

• 1 other identifier: NRX-KOR1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; TMS; NeuroAd; cognitive training; ADAS-Cog

Outcome Measures

Primary Outcomes (1)

• ADAS-Cog

  Alzheimer's disease assessment scale - cognitive test

  6 weeks

Study Arms (2)

NeuroAD

ACTIVE COMPARATOR

Treatment by the NeuroAD device, real treatment by synchronized TMS+cognitive training

Device: NeuroAD

Sham NeuroAD

SHAM COMPARATOR

Sham TMS+cog, has the same sound and appearance, patients come for the same number of treatments and are exposed to the same procedure.

Device: Sham device

Interventions

NeuroAD DEVICE

synchronized TMS+COGNITIVE TRAINING

Also known as: NICE

NeuroAD

Sham device DEVICE

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

Also known as: Control device

Sham NeuroAD

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• th grade education minimum

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuronix Ltd: lead
• company: K The Power: collaborator
• Chungnam National University Hospital: collaborator

Study Sites (1)

Chungnam national university hospital, Daejeon Geriatric Medical Center

Daejeon, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 5, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

KR (1)