Alzheimer's DiseaseNCT02166827
Effects of a NeuroAD System, for the Treatment of Alzheimer Disease
A study testing NeuroAD in people with Alzheimer's Disease, run by Neuronix Ltd at 1 site in Israel.
Trial summary
To evaluate the long-term efficacy of the NeuroAD system 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?
- NeuroAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Nov 2015
- 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
Main 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
- Physical clearance for study participation as evaluated by the clinician
- Spouse, family member or professional caregiver agree and capable of taking care for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
- Informed consent by the patient or by legally authorized person if appointed
Main Exclusion Criteria:
- CDR 0, 0.5 or 3
- Severe agitation
- Mental retardation
- History of Epileptic Seizures or Epilepsy
- Contraindication for performing MRI scanning
- Contraindication for receiving TMS treatment according to a TMS questionnaire
- Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
- Cardiac pacemakers
- Implanted medication pumps
- Intracardiac lines
- Significant heart disease
- Currently taking medication that lower the seizure threshold
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a NeuroAD System, for the Treatment of Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study
To evaluate the long-term efficacy of the NeuroAD system
Read the detailed description
To evaluate the long-term efficacy of the NeuroAD system in improvement of mild- to moderate Alzheimer patients' cognitive function
- Conditions
- Alzheimer's Disease
- Being tested
- NeuroAD, Sham TMS+Cog
- Keywords
- TMS, Cognitive Stimulation, 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.
NeuroADDevice
Also called NICE
Synchronized TMS and cognitive stimulation to 6 brain areas.
Sham TMS+CogDevice
Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises.
| Study group | Role | What they receive |
|---|---|---|
| NeuroAD | Active comparator | NeuroAd Treatment, synchronized TMS and cognitive training stimulation Receives: Device: NeuroAD |
| 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 TMS+Cog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Change from Baseline to 3 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change
Measured: 3 Months
Secondary outcomes (3)
Efficacy
Change from Baseline to week 7 in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change
Measured: 7 weeks
Efficacy
Change from Baseline to 6 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change
Measured: 6 Months
Efficacy
Change from Baseline to 9 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Administrative decision
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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronix Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166827
- Sponsor's protocol ID
- NRX-LT1
- Status last verified
- Mar 2017
- First submitted
- 15 Jun 2014
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a NeuroAD System, for the Treatment of Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02166827
- Acronym / sponsor ID
- NRX-LT1
- Conditions
- Alzheimer's Disease
- Keywords
- TMS, Cognitive Stimulation, NeuroAD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Neuronix LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Jun 2014 (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.
To evaluate the long-term efficacy of the NeuroAD system
Detailed description
To evaluate the long-term efficacy of the NeuroAD system in improvement of mild- to moderate Alzheimer patients' cognitive function
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: NeuroADNeuroAd Treatment, synchronized TMS and cognitive training stimulation |
| Sham TMS+Cog | Sham comparator | Device: Sham TMS+CogSham 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
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 |
|---|---|---|
| NeuroADAlso: NICESynchronized TMS and cognitive stimulation to 6 brain areas. | Device | NeuroAD |
| Sham TMS+CogSham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises. | Device | Sham TMS+Cog |
Primary outcome
Efficacy
Time frame: 3 Months
Change from Baseline to 3 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change
3 secondary outcomes
Efficacy
Time frame: 7 weeks
Efficacy
Time frame: 6 Months
Efficacy
Time frame: 9 Months
Results and safety
The study was stopped early (reason given: Administrative decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroAD in people with Alzheimer's Disease, run by Neuronix Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 was stopped early (reason given: Administrative decision). Results are not available in the source record.
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: 3 Months). 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 2017.