Alzheimer Disease, Early OnsetNCT00909285
Effects of Transcranial Magnetic Stimulation (TMS) and Cognitive Training for Alzheimer Patients
A study testing TMS stimulation and Cognitive training in people with Alzheimer Disease, Early Onset, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Current diagnosis of Alzheimer disease is made by clinical, neuropsychological, and neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific features, such as atrophy, which is a late feature in the progression of the disease. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease, Early Onset
- What is being tested?
- TMS stimulation and Cognitive training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Jul 2010
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 55-85 years
- Patients diagnosed with early or moderate stage of Alzheimer's disease, according to the DSM-IV criteria.
- MMSE score 15 to 26
- Global Dementia rating 1 or 2
- Physically acceptable for the study as confirmed by medical history and exam, clinical laboratory results and EKG
- Spouse, family member or professional caregiver agree and capable of taking care and responsibility for the participation of the patient in the study (transportation for the patient to and from the investigator's clinic, answering questions regarding the patient's condition and assuming responsibility for medication)
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- Written informed consent by patient or legally responsible caregiver.
- Able to undergo MRI scanning sessions (e.g., prior to the onset of the study, upon the attainment of the primary end-point and at the end of the study).
- Commitment to participation in six-to eighteen weeks of the trial regimen consisting of approximately1 hour TMS stimulation and cognitive training daily treatment of five days a week - six to eighteen weeks (and up to two treatments a day in case the Third TMS stimulation and cognitive training Treatment protocol if necessary).
Who cannot join
- Severe agitation;
- Mental retardation;
- Unstable medical condition;
- Use of benzodiazepines or other hypnotics during the study and preceding two weeks;
- Pharmacological immunosuppression;
- Participation in a clinical trial with any investigational agent within two weeks prior to study enrollment;
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- Alcoholism;
- History of Epileptic Seizures or Epilepsy;
- Contraindication for performing MRI scanning;
- Clinically significant abnormal laboratory findings which have not been approved by the Project Director;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Effects of TMS Stimulation and Cognitive Training for Alzheimer Patients: A Pilot Study
Current diagnosis of Alzheimer disease is made by clinical, neuropsychological, and neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific features, such as atrophy, which is a late feature in the progression of the disease. Therefore, developing new approaches for early and specific recognition of Alzheimer disease at the prodromal stages is of crucial importance.
In the present study the investigators would like to examine if combined treatment with TMS and cognitive training (CoTra) for several weeks can produce a sustained improvement in cognitive and behavioral symptomatology of Alzheimer's disease (AD) patients. A number of in vivo neuroimaging techniques, which can be used to reliably and noninvasively assess aspects of neuroanatomy, chemistry, physiology, and pathology, hold promise.
- Conditions
- Alzheimer Disease, Early Onset
- Being tested
- TMS stimulation, Sham comparator, Cognitive training
- Keywords
- Alzheimer, TMS, cognitive training
- 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 stimulationDevice
TMS stimulation and cognitive training
Sham comparatorDevice
Sham comparator
Cognitive trainingBehavioural
TMS stimulation and cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group (#1) | Experimental | Not described Receives: Device: TMS stimulation; Behavioral: Cognitive training |
| Control group (#2) | Sham comparator | Not described Receives: Device: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of the TMS stimulation with cognitive training in treatment of early- to mid- stage Alzheimer's patients will be established by improvement of at least 4 points on ADAS-COG.
Measured: 3 months
Secondary outcomes (1)
Safety will be established by paucity of related adverse events.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Shai Efrati, MD, Principal investigator, Assaf-Harofeh MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909285
- Sponsor's protocol ID
- NRX -NC-01
- Status last verified
- Jul 2010
- First submitted
- 24 May 2009
- Last updated
- 13 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effects of TMS Stimulation and Cognitive Training for Alzheimer Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT00909285
- Acronym / sponsor ID
- NRX -NC-01
- Conditions
- Alzheimer Disease, Early Onset
- Keywords
- Alzheimer, TMS, cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 27 May 2009 (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.
Current diagnosis of Alzheimer disease is made by clinical, neuropsychological, and neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific features, such as atrophy, which is a late feature in the progression of the disease. Therefore, developing new approaches for early and specific recognition of Alzheimer disease at the prodromal stages is of crucial importance.
In the present study the investigators would like to examine if combined treatment with TMS and cognitive training (CoTra) for several weeks can produce a sustained improvement in cognitive and behavioral symptomatology of Alzheimer's disease (AD) patients. A number of in vivo neuroimaging techniques, which can be used to reliably and noninvasively assess aspects of neuroanatomy, chemistry, physiology, and pathology, hold promise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (#1) | Experimental | Device: TMS stimulation, Behavioral: Cognitive training |
| Control group (#2) | Sham comparator | Device: Sham comparator |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female age 55-85 years
- Patients diagnosed with early or moderate stage of Alzheimer's disease, according to the DSM-IV criteria.
- MMSE score 15 to 26
- Global Dementia rating 1 or 2
- Physically acceptable for the study as confirmed by medical history and exam, clinical laboratory results and EKG
Key exclusion criteria (10 listed)
- Severe agitation;
- Mental retardation;
- Unstable medical condition;
- Use of benzodiazepines or other hypnotics during the study and preceding two weeks;
- Pharmacological immunosuppression;
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 stimulationTMS stimulation and cognitive training | Device | Treatment Group (#1) |
| Sham comparatorSham comparator | Device | Control group (#2) |
| Cognitive trainingTMS stimulation and cognitive training | Behavioural | Treatment Group (#1) |
Primary outcome
Evaluation of the efficacy of the TMS stimulation with cognitive training in treatment of early- to mid- stage Alzheimer's patients will be established by improvement of at least 4 points on ADAS-COG.
Time frame: 3 months
1 secondary outcome
Safety will be established by paucity of related adverse events.
Time frame: 3 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 13 Jul 2010.
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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.
Shai Efrati, MD principal investigator
Assaf-Harofeh MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS stimulation and Cognitive training in people with Alzheimer Disease, Early Onset, run by Assaf-Harofeh Medical Center 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 9 inclusion and 10 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 13 Jul 2010. 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 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?
Evaluation of the efficacy of the TMS stimulation with cognitive training in treatment of early- to mid- stage Alzheimer's patients will be established by improvement of at least 4 points on ADAS-COG. (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 13 Jul 2010.