Alzheimer's DiseasePhase 2NCT01179373
Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
A Phase 2 study testing TMS, H coil in people with Alzheimer's Disease, run by Brainsway at 1 site in Israel.
Trial summary
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- TMS, H coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Jun 2015
- Phase
- Phase 2
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 50-85.
- Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).
- Scored below 24 on the MMSE.
- Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response.
- Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
- Gave their oral and written consent to participate in the trial.
Who cannot join
- An additional neurological or psychiatric disorder.
- Severe personality disorder.
- Uncontrolled hypertension.
- History of epilepsy, seizure, or heat convulsion.
- History of epilepsy or seizure in first degree relatives.
- History of head injury or stroke.
Show all 13Show fewer
- History of metal implants in the head (except dental fillings).
- History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps.
- History of migraines in the last six months.
- History of drug or alcohol abuse.
- Inadequate communication with examiner.
- Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
- Inability to sign a consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.
Read the detailed description
Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months, 4 months.
Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2
Ages: 50-85 Genders: both
- Conditions
- Alzheimer's Disease
- Being tested
- TMS, H coil
- 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, H coilDevice
Also called TransCranial Magnetic Stimulation
TMS, H Coil, High/ Low Frequency
| Study group | Role | What they receive |
|---|---|---|
| TMS, High Frequency | Active comparator | High Frequency TMS with H coil to prefrontal cortex Receives: Device: TMS, H coil |
| TMS, Low Frequency | Active comparator | Low Frequency TMS to Prefrontal cortex Receives: Device: TMS, H coil |
| Sham Stimulation | Placebo comparator | Sham TMS with H Coil on Prefrontal Cortex Receives: Device: TMS, H coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive functioning score by ADAS-COG
Measured: 4 months
Secondary outcomes (3)
Global advancement score by CGI-C
Measured: 4 months
Frontal lobe functioning score by FAB
Measured: 4 months
Daily activity score by ADL
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2015
- Study completionJun 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179373
- Sponsor's protocol ID
- 10003
- Status last verified
- Jan 2018
- First submitted
- 8 Aug 2010
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01179373
- Acronym / sponsor ID
- 10003
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- Aug 2010 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Aug 2010 (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 primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.
Detailed description
Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months, 4 months.
Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2
Ages: 50-85 Genders: both
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TMS, High Frequency | Active comparator | Device: TMS, H coilHigh Frequency TMS with H coil to prefrontal cortex |
| TMS, Low Frequency | Active comparator | Device: TMS, H coilLow Frequency TMS to Prefrontal cortex |
| Sham Stimulation | Placebo comparator | Device: TMS, H coilSham TMS with H Coil on Prefrontal Cortex |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 50-85.
- Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).
- Scored below 24 on the MMSE.
- Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response.
- Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
Key exclusion criteria (13 listed)
- An additional neurological or psychiatric disorder.
- Severe personality disorder.
- Uncontrolled hypertension.
- History of epilepsy, seizure, or heat convulsion.
- History of epilepsy or seizure in first degree relatives.
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, H coilAlso: TransCranial Magnetic StimulationTMS, H Coil, High/ Low Frequency | Device | Sham Stimulation, TMS, High Frequency, TMS, Low Frequency |
Primary outcome
cognitive functioning score by ADAS-COG
Time frame: 4 months
3 secondary outcomes
Global advancement score by CGI-C
Time frame: 4 months
Frontal lobe functioning score by FAB
Time frame: 4 months
Daily activity score by ADL
Time frame: 4 months
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 25 Jan 2018.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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 Phase 2 study testing TMS, H coil in people with Alzheimer's Disease, run by Brainsway 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?
The sponsor lists 6 inclusion and 13 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 25 Jan 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
cognitive functioning score by ADAS-COG (time frame: 4 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 25 Jan 2018.