Alzheimer DiseasePhase 1/2LIWANCT02204969
LIWA for Treatment of Alzheimer Patients
A Phase 1/2 study testing Lithia water and Transcranial Magnetic stimulation in people with Alzheimer Disease, run by American Society Of Thermalism And Climatology Inc at 1 site in United States.
Trial summary
The thermal therapy combined with magnetic fields and ozone has a direct effect on patients with dementia and Alzheimer's with a regression of more than 60% of them Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Lithia water and Transcranial Magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 1/2
- 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 80 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 half a year (by the DSM-IV criteria).
- Scored 16-26 on the MMSE.
- Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks.
- Existence of a routine therapist for changes or adverse effects reports.
- Existence of Alzheimer diagnosis by CT or MRI tests.
- 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 disorder.
- Severe psychiatric disorder.
- Uncontrolled hypertension, beyond 170/110.
- History of epilepsy, seizure, or heat convulsion or History of epilepsy or seizure in first degree relatives.
- History of head injury or stroke.
- History of metal implants in the head (except dental fillings)or History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neuro stimulators, or any medical pumps.
Show all 12Show fewer
- 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.
- Leukemia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Gaviota Clinic
Newark, New Jersey, 07105
Garis Silega, Dr, 862-229-4766, drsilega@aol.com
Garis Silega, Dr
About this study
Official title: Transcranial Magnetic Stimulation (TMS) and Lithium Water for Treatment of Alzheimer Patients
The thermal therapy combined with magnetic fields and ozone has a direct effect on patients with dementia and Alzheimer's with a regression of more than 60% of them
Read the detailed description
Alzheimer's disease (AD) is the leading cause of dementia and cognitive deteriorating in the advanced age. This main target of this study is to determine the safety and efficacy of transcranial magnetic stimulation (TMS) using novel coil design (H2) for stimulation of deep brain structures concomitantly with regular treatment in Alzheimer's disease (AD) patients. TMS acts by generating magnetic fields in the brain which simulate neuro-chemical changes and stimulate neuronal activity translating into increased secretion of growth factors such as brain derived neurotropic factor (BDNF). Hence it is postulated that TMS will have a positive effect on the cognitive and behavioral symptoms of patients with AD and may ameliorated the progression of the disease. The treatment is non-invasive, with no significant side effects, and no need of hospitalization or anesthesia. The trial is phase II double blind study including 100 AD patients ages between 50 to 80 with mild or moderate AD (Mini Mental State Examination [MMSE] 16 to 26) divided into 3 groups. All participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and then 1 treatment per week for additional 4 weeks. Patients will be evaluated before the treatments, after 8 weeks of treatment and after another 8 weeks without treatment. The evaluations will include cognitive function according to ADAS-COG and MMSE, Activity of daily living (ADL) functions according to ADSC-ADL, behavioral function according to the Neuropsychiatric Inventory (NPI), depression according to the Cornell Scale for Depression in Dementia (CSDD), care giver satisfaction according to the RUD LITE scale and computerized cognitive evaluation according to the NEXING battery. We expect that the cognitive, behavioral and ADL functions will improve better in the study group as compared to the Sham treated group. From previous trial of TMS in neurological patients, although not in AD, we anticipate that adverse events rate will be similar between groups proving the safety of deep TMS treatment in patients with AD. In case our hypothesis will be proven, deep TMS treatment will be added as an important modality to the conventional therapy of AD patients.
All patients will be received 500 mcg/d of lithium as supplement nutritional in form spring mineral water
- Conditions
- Alzheimer Disease
- Being tested
- Lithia water, Transcranial Magnetic stimulation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithia waterDietary supplement
Also called pring Mineral water
- Experimental: Lithia spring water Lithia water (active) for 4 weeks then placebo water for 4 weeks Intervention: Dietary Supplement: Lithia water
- Placebo Comparator: Natural spring water Placebo water for 4 weeks then lithia water (active) for 4 weeks Intervention: Dietary Supplement: Natural spring water with negligible lithium levels
Transcranial Magnetic stimulationDevice
Also called novel coil design (H2)
All participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and then 1 treatment per week for additional 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial magnetic stimulation | Sham comparator | All participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and then 1 treatment per week for additional 4 weeks. Receives: Device: Transcranial Magnetic stimulation |
| lithia water | Placebo comparator | * Experimental: Lithia spring water Lithia water (active) for 4 weeks then placebo water for 4 weeks Intervention: Dietary Supplement: Lithia water
* Placebo Comparator: Natural spring water Placebo water for 4 weeks then lithia water (active) for 4 weeks Intervention: Dietary Supplement: Natural spring water with negligible lithium levels Receives: Dietary Supplement: Lithia water |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Society Of Thermalism And Climatology Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garis Silega, Dr, Principal investigator, American Society of Thermalism and Climatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204969
- Sponsor's protocol ID
- 822429989
- Acronym
- LIWA
- Status last verified
- Jan 2015
- First submitted
- 28 Jul 2014
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation (TMS) and Lithium Water for Treatment of Alzheimer Patients
- ClinicalTrials.gov ID
- NCT02204969
- Acronym / sponsor ID
- LIWA / 822429989
- Conditions
- Alzheimer Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- American Society Of Thermalism And Climatology IncUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 Jul 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.
The thermal therapy combined with magnetic fields and ozone has a direct effect on patients with dementia and Alzheimer's with a regression of more than 60% of them
Detailed description
Alzheimer's disease (AD) is the leading cause of dementia and cognitive deteriorating in the advanced age. This main target of this study is to determine the safety and efficacy of transcranial magnetic stimulation (TMS) using novel coil design (H2) for stimulation of deep brain structures concomitantly with regular treatment in Alzheimer's disease (AD) patients. TMS acts by generating magnetic fields in the brain which simulate neuro-chemical changes and stimulate neuronal activity translating into increased secretion of growth factors such as brain derived neurotropic factor (BDNF). Hence it is postulated that TMS will have a positive effect on the cognitive and behavioral symptoms of patients with AD and may ameliorated the progression of the disease. The treatment is non-invasive, with no significant side effects, and no need of hospitalization or anesthesia. The trial is phase II double blind study including 100 AD patients ages between 50 to 80 with mild or moderate AD (Mini Mental State Examination [MMSE] 16 to 26) divided into 3 groups. All participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and then 1 treatment per week for additional 4 weeks. Patients will be evaluated before the treatments, after 8 weeks of treatment and after another 8 weeks without treatment. The evaluations will include cognitive function according to ADAS-COG and MMSE, Activity of daily living (ADL) functions according to ADSC-ADL, behavioral function according to the Neuropsychiatric Inventory (NPI), depression according to the Cornell Scale for Depression in Dementia (CSDD), care giver satisfaction according to the RUD LITE scale and computerized cognitive evaluation according to the NEXING battery. We expect that the cognitive, behavioral and ADL functions will improve better in the study group as compared to the Sham treated group. From previous trial of TMS in neurological patients, although not in AD, we anticipate that adverse events rate will be similar between groups proving the safety of deep TMS treatment in patients with AD. In case our hypothesis will be proven, deep TMS treatment will be added as an important modality to the conventional therapy of AD patients.
All patients will be received 500 mcg/d of lithium as supplement nutritional in form spring mineral water
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial magnetic stimulation | Sham comparator | Device: Transcranial Magnetic stimulationAll participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and then 1 treatment per week for additional 4 weeks. |
| lithia water | Placebo comparator | Dietary Supplement: Lithia water* Experimental: Lithia spring water Lithia water (active) for 4 weeks then placebo water for 4 weeks Intervention: Dietary Supplement: Lithia water * Placebo Comparator: Natural spring water Placebo water for 4 weeks then lithia water (active) for 4 weeks Intervention: Dietary Supplement: Natural spring water with negligible lithium levels |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged 50-85.
- Diagnosed with Alzheimer's disease for at least half a year (by the DSM-IV criteria).
- Scored 16-26 on the MMSE.
- Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks.
- Existence of a routine therapist for changes or adverse effects reports.
Key exclusion criteria (12 listed)
- An additional neurological disorder.
- Severe psychiatric disorder.
- Uncontrolled hypertension, beyond 170/110.
- History of epilepsy, seizure, or heat convulsion or History of epilepsy or seizure in first degree relatives.
- History of head injury or stroke.
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 |
|---|---|---|
| Lithia waterAlso: pring Mineral water* Experimental: Lithia spring water Lithia water (active) for 4 weeks then placebo water for 4 weeks Intervention: Dietary Supplement: Lithia water * Placebo Comparator: Natural spring water Placebo water for 4 weeks then lithia water (active) for 4 weeks Intervention: Dietary Supplement: Natural spring water with negligible lithium levels | Dietary supplement | lithia water |
| Transcranial Magnetic stimulationAlso: novel coil design (H2)All participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and then 1 treatment per week for additional 4 weeks. | Device | Transcranial magnetic stimulation |
Primary outcome
Cognitive functioning score by ADAS-COG
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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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.
Garis Silega, Dr principal investigator
American Society of Thermalism and Climatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lithia water and Transcranial Magnetic stimulation in people with Alzheimer Disease, run by American Society Of Thermalism And Climatology Inc 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 8 inclusion and 12 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 6 Jan 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 6 Jan 2015.