Alzheimer's DementiaNCT01195389
Safety and Efficacy Study of Magnetic Fields to Treat Alzheimer's Disease
A study testing Resonator in people with Alzheimer's Dementia, run by pico-tesla Magnetic Therapies, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine if low level magnetic fields can help to improve memory in patients diagnosed with Alzheimer's dementia. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer's Dementia
- What is being tested?
- Resonator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Oct 2011
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of Alzheimer's Disease appropriately documented by the patients physician and/or neurologist
- Documentation verifying that other generally recognized causes of dementia have been ruled out by prior physician evaluations
- Mild to Moderate Dementia, as evidenced by a score of not less than 12 nor greater than 26 on the Mini Mental Status Exam (MMSE).
- Subject is ambulatory.
- A Study Partner who can attend all study visits with the subject. Study Partner being defined as an adult who has at least 10 hours/week of contact with the subject, and can accompany the subject to all testing and treatment study visits.
- Stable "anti-dementia" medication regimen without significant side effects for at least 3 months, and on stable medication (unrelated to anti-dementia) without significant side effects for at least 1 month; willingness and ability to maintain the stable medication regimen throughout the course of the study.
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- Willingness and ability to present to the testing center for all study evaluations
- Willingness and ability to present to the treatment center for all study treatments (exposure to the Resonator™)
- Willingness to maintain stable diet and activity regimen for the duration of the study.
- Willing and able to abstain from partaking in any non-essential (not physician ordered) existing or new treatments to improve cognition and mental functioning
- Willing and able to abstain from any medications that could affect cognition and mental functioning during the course of the study
- Male or female.
- Any ethnic background.
- Age 55 and older.
Who cannot join
- Change in anti-dementia medical regimen within 3 months prior to initiation of study.
- Confirmed diagnosis other non-Alzheimer's type of dementia
- Significant neurologic or psychiatric illness other than Alzheimer's disease
- Unstable cardiac disease, such as any history of cardiac arrhythmias (including atrial fibrillation, ventricular fibrillation, or irregular atrial-ventricular conduction time), or any incidences of congestive heart failure, or myocardial infarction, within the last six months.
- Previous surgical interventions involving prosthetics or implants comprised of ferrous metals, or pacemakers, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain.
- Reported consumption of more than 14 alcoholic drinks per week.
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- Uncontrolled hypertension.
- Uncontrolled atrial fibrillation or other uncontrolled arrhythmias, e.g. tachycardia, bradycardia.
- Uncontrolled seizure disorder.
- History of seizures or usage of anti-seizure medications that, in the opinion of the investigator, participation in this trial would represent a risk to the subject.
- Uncontrolled, unstable, or untreated medical conditions which may significantly impact the subject's health or ability to complete the entire study, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
Amanda Smith, MD contact
United States1 site, 1 recruiting
- Recruiting
USF Health Byrd Alzheimer's Institute
Tampa, Florida, 33613
Amanda Smith, MD, 813-974-4355
Amanda Smith, MD
About this study
Official title: A Randomized, Single-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety and Efficacy of the Application of Magnetic Fields Using the Resonator for the Treatment of Alzheimer's Disease in Addition to Standard of Care
The purpose of this study is to determine if low level magnetic fields can help to improve memory in patients diagnosed with Alzheimer's dementia.
Read the detailed description
The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator result in statistically significant improvements in cognitive functioning and memory in patients with a diagnosis of Alzheimer's dementia.
- Conditions
- Alzheimer's Dementia
- Being tested
- Resonator
- Keywords
- dementia, memory loss, cognitive decline
- Medical subject headings
- Alzheimer Disease, Dementia, Memory Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResonatorDevice
Treatment group vs. Placebo group
| Study group | Role | What they receive |
|---|---|---|
| Resonator | Active comparator | Treatment with active Resonator device using low level magnetic fields Receives: Device: Resonator |
| Placebo treatment | Placebo comparator | Not described Receives: Device: Resonator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-Cog (ADAS-cog)
Measured: end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DementiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- pico-tesla Magnetic Therapies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Amanda Smith, MD, Principal investigator, University South Florida Health Byrd Alzheimer's Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195389
- Sponsor's protocol ID
- USF #6178-P67865
- Status last verified
- Jun 2011
- First submitted
- 1 Sep 2010
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety and Efficacy of the Application of Magnetic Fields Using the Resonator for the Treatment of Alzheimer's Disease in Addition to Standard of Care
- ClinicalTrials.gov ID
- NCT01195389
- Acronym / sponsor ID
- USF #6178-P67865
- Conditions
- Alzheimer's Dementia
- Keywords
- dementia, memory loss, cognitive decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- pico-tesla Magnetic Therapies, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 6 Sep 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 purpose of this study is to determine if low level magnetic fields can help to improve memory in patients diagnosed with Alzheimer's dementia.
Detailed description
The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator result in statistically significant improvements in cognitive functioning and memory in patients with a diagnosis of Alzheimer's dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resonator | Active comparator | Device: ResonatorTreatment with active Resonator device using low level magnetic fields |
| Placebo treatment | Placebo comparator | Device: Resonator |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Current diagnosis of Alzheimer's Disease appropriately documented by the patients physician and/or neurologist
- Documentation verifying that other generally recognized causes of dementia have been ruled out by prior physician evaluations
- Mild to Moderate Dementia, as evidenced by a score of not less than 12 nor greater than 26 on the Mini Mental Status Exam (MMSE).
- Subject is ambulatory.
- A Study Partner who can attend all study visits with the subject. Study Partner being defined as an adult who has at least 10 hours/week of contact with the subject, and can accompany the subject to all testing and treatment study visits.
Key exclusion criteria (11 listed)
- Change in anti-dementia medical regimen within 3 months prior to initiation of study.
- Confirmed diagnosis other non-Alzheimer's type of dementia
- Significant neurologic or psychiatric illness other than Alzheimer's disease
- Unstable cardiac disease, such as any history of cardiac arrhythmias (including atrial fibrillation, ventricular fibrillation, or irregular atrial-ventricular conduction time), or any incidences of congestive heart failure, or myocardial infarction, within the last six months.
- Previous surgical interventions involving prosthetics or implants comprised of ferrous metals, or pacemakers, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain.
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 |
|---|---|---|
| ResonatorTreatment group vs. Placebo group | Device | Placebo treatment, Resonator |
Primary outcome
Alzheimer's Disease Assessment Scale-Cog (ADAS-cog)
Time frame: end of treatment at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
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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.
Amanda Smith, MD contact
Amanda Smith, MD principal investigator
University South Florida Health Byrd Alzheimer's Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resonator in people with Alzheimer's Dementia, run by pico-tesla Magnetic Therapies, LLC at 1 site in United States.
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 14 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Jul 2011. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Smith, MD (813-974-4355), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale-Cog (ADAS-cog) (time frame: end of treatment at 12 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 8 Jul 2011.