Alzheimer's DiseasePhase 2NCT01885806
Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease
A Phase 2 study testing Magnetic Stimulator Magstim Rapid 2 in people with Alzheimer's Disease and Apathy, run by Federal University of Minas Gerais at 2 sites in Brazil.
Trial summary
We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer's Disease, Apathy
- What is being tested?
- Magnetic Stimulator Magstim Rapid 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2013to Dec 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 60 to 85 years-old
- Mild or moderate Alzheimer's disease (MMSE scores between 10 and 20)
- Apathy diagnosis
- On stable doses of cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 6 months prior to enrollment
Who cannot join
- history of epilepsy or convulsions
- History of migraine or headaches episodes twice per week or more
- History of neurodegenerative diseases other than Alzheimer's disease
- Current use of first generation antipsychotics, clozapine, tricyclic drugs or anticonvulsants
- History of cerebral ischemic episode
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Federal University of Minas Gerais
Belo Horizonte, Outside of U.S., 30130-100
Marco A Romano-Silva, MD, PhD, +55 31 3409-9758, romanosilva@gmail.com
Breno S Diniz, MD, PhD
- Recruiting
Federal University of Minas Gerais
Belo Horizonte, Outside of U.S., 30130-100
Marco A Romano-Silva, MD, PhD, +55 31 3409-9785, romanosilva@gmail.com
Breno S Diniz, MD, PhD
About this study
Official title: Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease: a Randomised, Double-blind, Controlled Study
We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.
Read the detailed description
This study aims to enroll 40 patients with mild and moderate Alzheimer's disease with apathy symptoms that will be randomized to receive rTMS or sham procedure. Subjects will be randomized in two arms (rTMS or sham procedure) in 1:1 proportion.
Eligibility criteria:
- Diagnosis of Alzheimer's disease, mild and moderate stage (MMSE range from 10 to 20);
- Diagnosis of apathy;
- age between 60 and 85 years-old;
- On stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment;
The primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores.
- Conditions
- Alzheimer's Disease, Apathy
- Being tested
- Magnetic Stimulator Magstim Rapid 2, Sham Magnetic Stimulator
- Keywords
- Apathy; Alzheimer's disease; Cognition; Burden of Care
- Medical subject headings
- Alzheimer Disease, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Stimulator Magstim Rapid 2Device
Also called rTMS
All procedures will use the Magnetic Stimulator Magstim Rapid 2. Total of session: 10 rTMS protocol: Freqüency: 10 Hz Intensity: 90% limiar motor Session duration: 16 minutes (20 TMS sequences of 6 second with intervals of 30 seconds between each sequence) Location: Left dorsolateral pre-frontal cortex
Sham Magnetic StimulatorDevice
Also called Sham
This intervention will follow the same protocol of the rTMS except that subjects will not receive magnetic stimulation of the brain.
Total of session: 10
| Study group | Role | What they receive |
|---|---|---|
| Repetitive TMS | Experimental | Patients will receive 10 consecutive sessions of repetitive transcranial magnetic stimulation with the following protocol:
Frequency: 10 Hz Intensity: 90% motor limiar Session duration: 16 minutes (20 sequencies of 6 seconds of stimulation followed by intervals of 30 seconds); Localization: Left pre-frontal dorsolateral cortex; Receives: Device: Magnetic Stimulator Magstim Rapid 2 |
| Sham TMS | Sham comparator | Patients will receive 10 consecutive sessions of sham transcranial magnetic stimulation following the same protocol as the intervention arm, but with no magnetic stimulation of the brain. Receives: Device: Sham Magnetic Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in apathy symptoms
Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment.
Measured: 12 weeks
Secondary outcomes (2)
Change in ADAS-Cog scores
Improvement in ADAS-Cog scores between baseline and 12 weeks after treatment.
Measured: 12 weeks
Change in the Zarit Burden Scale
Reduction in the Zarit Burden Scale between baseline and 12 weeks after treatment.
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 posted25 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014 (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'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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Breno Satler de Oliveira Diniz, Federal University of Minas Gerais
- Investigators
- Breno S Diniz, MD, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885806
- Sponsor's protocol ID
- CAAE: 15388913.6.0000.5149
- Status last verified
- Jun 2013
- First submitted
- 18 Jun 2013
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease: a Randomised, Double-blind, Controlled Study
- ClinicalTrials.gov ID
- NCT01885806
- Acronym / sponsor ID
- CAAE: 15388913.6.0000.5149
- Conditions
- Alzheimer's Disease, Apathy
- Keywords
- Apathy; Alzheimer's disease; Cognition; Burden of Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Jun 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.
We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.
Detailed description
This study aims to enroll 40 patients with mild and moderate Alzheimer's disease with apathy symptoms that will be randomized to receive rTMS or sham procedure. Subjects will be randomized in two arms (rTMS or sham procedure) in 1:1 proportion.
Eligibility criteria:
- Diagnosis of Alzheimer's disease, mild and moderate stage (MMSE range from 10 to 20);
- Diagnosis of apathy;
- age between 60 and 85 years-old;
- On stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment;
The primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive TMS | Experimental | Device: Magnetic Stimulator Magstim Rapid 2Patients will receive 10 consecutive sessions of repetitive transcranial magnetic stimulation with the following protocol: Frequency: 10 Hz Intensity: 90% motor limiar Session duration: 16 minutes (20 sequencies of 6 seconds of stimulation followed by intervals of 30 seconds); Localization: Left pre-frontal dorsolateral cortex; |
| Sham TMS | Sham comparator | Device: Sham Magnetic StimulatorPatients will receive 10 consecutive sessions of sham transcranial magnetic stimulation following the same protocol as the intervention arm, but with no magnetic stimulation of the brain. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 60 to 85 years-old
- Mild or moderate Alzheimer's disease (MMSE scores between 10 and 20)
- Apathy diagnosis
- On stable doses of cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 6 months prior to enrollment
Key exclusion criteria (5 listed)
- history of epilepsy or convulsions
- History of migraine or headaches episodes twice per week or more
- History of neurodegenerative diseases other than Alzheimer's disease
- Current use of first generation antipsychotics, clozapine, tricyclic drugs or anticonvulsants
- History of cerebral ischemic episode
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 |
|---|---|---|
| Magnetic Stimulator Magstim Rapid 2Also: rTMSAll procedures will use the Magnetic Stimulator Magstim Rapid 2. Total of session: 10 rTMS protocol: Freqüency: 10 Hz Intensity: 90% limiar motor Session duration: 16 minutes (20 TMS sequences of 6 second with intervals of 30 seconds between each sequence) Location: Left dorsolateral pre-frontal cortex | Device | Repetitive TMS |
| Sham Magnetic StimulatorAlso: ShamThis intervention will follow the same protocol of the rTMS except that subjects will not receive magnetic stimulation of the brain. Total of session: 10 | Device | Sham TMS |
Primary outcome
Change in apathy symptoms
Time frame: 12 weeks
Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment.
2 secondary outcomes
Change in ADAS-Cog scores
Time frame: 12 weeks
Change in the Zarit Burden Scale
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
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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.
Breno S Diniz, MD, PhD principal investigator
Federal University of Minas Gerais
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnetic Stimulator Magstim Rapid 2 in people with Alzheimer's Disease and Apathy, run by Federal University of Minas Gerais at 2 sites in Brazil.
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 4 inclusion and 5 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 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Breno S Diniz, MD, PhD (+55 31 97950860, brenosatler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in apathy symptoms (time frame: 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 25 Jun 2013.