Alzheimer's DiseaseNCT01825330
Effect of NeuroAD on the Cognitive Function of Alzheimer Patients
A study testing TMS and cognitive stimulation in people with Alzheimer's Disease, run by Neuronix Ltd at 10 sites in 2 countries.
Trial summary
The study tests the effect of the NeuroAD on Alzheimer patients' cognitive function. The NeuroAD uses non-invasive stimulation of both magnetic and cognitive training. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- TMS and cognitive stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Oct 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Physical clearance for study participation as evaluated by the clinician.
- 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)
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- Agreement to participate in approximately 14 weeks during the study.
- Normal to near-normal vision and hearing with correction as needed (e.g. corrective lenses, hearing aid).
- Fluent in English or Hebrew
- Minimum of 8th grade education
- If medicated for AD, then use of cholinesterase inhibitors, memantine or Ginko-biloba for at least 3 months and on stable dose for at least 60 days prior to screening.
Who cannot join
- CDR 0, 0.5 or 3
- Severe agitation
- Mental retardation
- Patient lacking capacity to consent to study participation
- Unstable medical condition
- Use of benzodiazepines or barbiturates 2 weeks prior to screening
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- Pharmacological immunosuppression
- Participation in a clinical trial with any investigational agent within 6 months 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 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 with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators, aneurysm clips) with the exception of metal implants in mouth
- Patients with personal history of either any clinically defined medical disorder (which the investigator finds as interfering with the study) or any clinically defined neurological/psychiatric disorder (other than AD), including (but not limited to): epilepsy, stroke, brain lesions, substance abuse, vitamin B12 deficiency, abnormal thyroid function, cerebrovascular condition, other neurodegenerative disease, head trauma, multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness.
- Patients with any signs or symptoms of increased intracranial pressure, as determined in a neurological exam.
- Cardiac pacemakers
- Implanted medication pumps
- Intracardiac lines
- Significant heart disease
- Currently taking medication that lower the seizure threshold.
- Patients on which TMS Motor Threshold cannot be found.
- Patient underwent TMS treatment in the past.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cleveland Clinic Center for Brain Health Lakewood Hospital
Cleveland, Ohio, 44107
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
Cleveland Clinic Lou Ruvo Brain Center
Las Vegas, Nevada, 89106
Miami Jewish Health Systems
Miami, Florida, 33137
NYU Langone Medical Center
New York, New York, 10016
Roskamp Institute Clinic
Sarasota, Florida, 34243
Banner Sun Health Research Institute
Sun City, Arizona, 85351
Palm Beach Neurology and Premiere Research Institute
West Palm Beach, Florida, 33407
About this study
Official title: Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
The study tests the effect of the NeuroAD on Alzheimer patients' cognitive function. The NeuroAD uses non-invasive stimulation of both magnetic and cognitive training.
Read the detailed description
The NeuroAD system is a combined system of Transcranial Magnetic Stimulation and cognitive training and is a non-invasive therapeutic system for the improvement of Alzheimer patients' cognitive function.
A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment or sham (placebo) Patient will attend the clinic 5 times a week for 6 weeks, approximately an hour every day for treatment/sham. The patient will be required to return to the clinic for follow-up.
Up to 150 patients will be enrolled in up to 10 clinical sites in the US and Israel.
- Conditions
- Alzheimer's Disease
- Being tested
- TMS and cognitive stimulation, sham
- Keywords
- Alzheimer's Disease, Alzheimer's, TMS, Cognitive Training, NeuroAD
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS and cognitive stimulationDevice
Also called NeuroAD, NICE
Synchronized TMS and cognitive stimulation to 6 brain areas.
shamDevice
| Study group | Role | What they receive |
|---|---|---|
| NeuroAD | Active comparator | NeuroAD treatment, synchronized TMS and cognitive training stimulation Receives: Device: TMS and cognitive stimulation |
| Sham TMS+Cog | Sham comparator | Sham device, has the same appearance and sound as the real device, combined with sham cognitive exercises. Patients come for the same number of sessions, delivers no real stimulation or cognitive training. Receives: Device: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
Measured: 7 weeks
Secondary outcomes (2)
Efficacy
Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change
Measured: 7 weeks
Efficacy
Change from baseline to week 12 in ADAS-Cog score.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronix Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlie Bernick, MD, Principal investigator, Lou Ruvo Brain Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825330
- Sponsor's protocol ID
- NRX - US4
- Status last verified
- Oct 2015
- First submitted
- 24 Mar 2013
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
- ClinicalTrials.gov ID
- NCT01825330
- Acronym / sponsor ID
- NRX - US4
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Alzheimer's, TMS, Cognitive Training, NeuroAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Neuronix LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study tests the effect of the NeuroAD on Alzheimer patients' cognitive function. The NeuroAD uses non-invasive stimulation of both magnetic and cognitive training.
Detailed description
The NeuroAD system is a combined system of Transcranial Magnetic Stimulation and cognitive training and is a non-invasive therapeutic system for the improvement of Alzheimer patients' cognitive function.
A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment or sham (placebo) Patient will attend the clinic 5 times a week for 6 weeks, approximately an hour every day for treatment/sham. The patient will be required to return to the clinic for follow-up.
Up to 150 patients will be enrolled in up to 10 clinical sites in the US and Israel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroAD | Active comparator | Device: TMS and cognitive stimulationNeuroAD treatment, synchronized TMS and cognitive training stimulation |
| Sham TMS+Cog | Sham comparator | Device: shamSham device, has the same appearance and sound as the real device, combined with sham cognitive exercises. Patients come for the same number of sessions, delivers no real stimulation or cognitive training. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Physical clearance for study participation as evaluated by the clinician.
Key exclusion criteria (24 listed)
- CDR 0, 0.5 or 3
- Severe agitation
- Mental retardation
- Patient lacking capacity to consent to study participation
- Unstable medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS and cognitive stimulationAlso: NeuroAD, NICESynchronized TMS and cognitive stimulation to 6 brain areas. | Device | NeuroAD |
| sham | Device | Sham TMS+Cog |
Primary outcome
Efficacy
Time frame: 7 weeks
Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
2 secondary outcomes
Efficacy
Time frame: 7 weeks
Efficacy
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Sponsor's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlie Bernick, MD principal investigator
Lou Ruvo Brain Center
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS and cognitive stimulation in people with Alzheimer's Disease, run by Neuronix Ltd at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.