rTMS active treatment for Alzheimer Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
Monash University, Melbourne, Australia
Alzheimer Disease+1 More
rTMS active treatment - Device
Eligibility
18+
All Sexes
Eligible conditions
Alzheimer Disease

Study Summary

This study is evaluating whether repetitive Transcranial Magnetic Stimulation (rTMS) treatment can improve memory in people with Alzheimer's disease.

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Eligible Conditions

  • Alzheimer Disease
  • Alzheimer's Disease (AD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether rTMS active treatment will improve 1 primary outcome and 10 secondary outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Weeks 0 and 5.

Week 5
Semantic Fluency Test (SFT)
Week 29
Clinical Dementia Rating (CDR) sum of boxes
Weeks 0 and 5
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) change
Week 4
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) effect over time
Week 4
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Digit Span Test
Neuropsychiatric Inventory-Questionnaire (NPI-Q)
Stroop Test
Verbal Fluency Test (VFT)
Zarit Burden Interview (ZBI)
Week 4
Treatment Satisfaction Questionnaire for Medication (TSQM)

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

2 weeks sham treatment
4 weeks active treatment
Placebo group

This trial requires 200 total participants across 4 different treatment groups

This trial involves 4 different treatments. RTMS Active Treatment is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

4 weeks active treatment
Device
4 weeks of rTMS active treatment applied using an active rTMS coil.
2 weeks active treatment
Device
2 weeks of rTMS active treatment applied using an active rTMS coil.
2 weeks sham treatment
Device
2 weeks of rTMS sham treatment applied using a modified rTMS coil which does not stimulate the brain.
4 weeks sham treatment
Device
4 weeks of rTMS sham treatment applied using a modified rTMS coil which does not stimulate the brain.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly weeks 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups for reporting.

Closest Location

Riverview Health Center - Winnipeg, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Individuals must have a MoCA score between 7 and 25, indicating mild cognitive impairment or dementia, a CDR score of 1-2, and a CSDD score of 18 or less.
Participants must have probable early or moderate Alzheimer's disease as confirmed by their treating neurologist, geriatrician, or psychiatrist, and/or by the study doctors.
Participants must be +55 years old.
Participants must be taking a stable dose of an acetylcholinesterase inhibitor for at least 3 months prior to study entry with no plans to change medication for the duration of the study. Or if participants decide to stop taking their Alzheimer's disease related medication, they must wait a minimum of 6 weeks prior to the start of the intervention.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does rtms active treatment work?

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Results showed that subjects demonstrated improvement in cognitive complaints and activities of daily living. The rtms was superior to the placebo in the group's response to the treatment. A large, double-blind, placebo-controlled, randomized trial is warranted to verify these findings.

Unverified Answer

What causes alzheimer disease?

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While both Alzheimer disease and vascular dementia are strongly associated with increased intracranial haemorrhage, the haemorrhagic stroke that occurs most often causes cerebral white matter lesions, whereas Alzheimer disease is mainly associated with a non-stroke 'diffuse' type of lesion. Other vascular diseases, e.g.

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What is alzheimer disease?

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Alzheimer disease (AD) is a form of progressive neuronal degeneration with prominent clinical features including cognitive impairment, personality/behaviour changes, and functional decline. The exact cause for most cases of AD is currently unknown, but genetics and environmental factors are considered to play a role.

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Can alzheimer disease be cured?

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Although the cause and cure of AD are still unknown, even though a number of promising therapies have been developed to improve the symptoms, a cure for AD is yet to be found. However, one possible treatment exists that improves symptoms and slows down disease progression. The treatment option involves maintaining or increasing adherence to a Mediterranean diet.

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How many people get alzheimer disease a year in the United States?

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About 1 in 7 elderly American men have dementia due to Alzheimer's disease annually. This figure is higher than in women because more women are diagnosed later than men, but still only make up 42% of Alzheimer's disease cases. About 200,000 US citizens have been diagnosed with at least one type of dementia in the past 4 years. In this decade, over 1 in 4 Americans over the age of 65 have dementia. In the US, about 10,000 people die from Alzheimer's disease each year.

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What are common treatments for alzheimer disease?

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There can be a variety of treatments for Alzheimer's disease. It is important to realize that not all treatment strategies are approved by the FDA. Most of the treatment guidelines are not completely evidence-based.

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What are the signs of alzheimer disease?

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Signs of Alzheimer disease include mood swings, memory problems and behavioural changes. Although the exact cause of Alzheimer's disease cannot yet be determined, it appears some of these symptoms are reversible with treatment.\n

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Who should consider clinical trials for alzheimer disease?

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Given these clinical trials options, it is important to consider patients' willingness, capacity to participate, preferences and other specific clinical need, and the importance that patients place on their treatment decisions.

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Is rtms active treatment typically used in combination with any other treatments?

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The frequency with which different treatment combinations for AD and PD were employed in the treatment trials did not reflect their use in clinical practice; however, most of the trials for these two diseases employed combinations that have been found to contribute to an overall benefit.

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What is rtms active treatment?

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Rtl-treatment (and rtl-treatment in combination with huperzine-A) in Alzheimer's disease and rtms-treatment in schizophrenia may significantly reduce the number of depressive and positive symptoms of the diseases compared to placebo. The drugs may be also safe and non-toxic as compared to other used psychotrophics.

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Have there been any new discoveries for treating alzheimer disease?

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There is a lack of new discoveries specifically for Alzheimer's disease at this time and it seems we must rely on existing treatments for the disease in order to survive. Despite this, there are several promising therapies under development; it is important to remain aware of these new treatments as they may be important in the near future. New discoveries in Alzheimer's disease are extremely rare. The most frequently investigated treatments are those that help slow down the progression of the disease or improve symptoms; these include treatments that reduce beta amyloid plaque and treatments that help keep neurogenesis in place. New therapies are needed to help prevent the disease in the first place and also to treat it when it is already present. Many older therapeutics target amyloid beta plaques.

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What are the latest developments in rtms active treatment for therapeutic use?

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Currently, one of the most challenging decisions in therapeutic management of the elderly patient with cognitive impairment is the choice of the appropriate treatment. An integrated approach by combining pharmacological, cholinergic and noncholinergic treatment options has led to the development of a comprehensive treatment strategy, achieving a more effective and safer long-term outcome in patients with normal and impaired cognition.

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