CLINICAL TRIAL

Personalized tDCS for Alzheimer Disease

Recruiting · 65+ · All Sexes · Roslindale, MA

This study is evaluating whether a specific type of brain stimulation may help improve mobility for individuals with Alzheimer's disease.

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About the trial for Alzheimer Disease

Eligible Conditions
Presenile Alzheimer Dementia · Dementia · Dementia of the Alzheimer's Type · Aging · Alzheimer Disease

Treatment Groups

This trial involves 2 different treatments. Personalized TDCS is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Personalized tDCS
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Active-Sham
OTHER

Eligibility

This trial is for patients born any sex aged 65 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Men and women aged 65 and older living within supportive housing facilities
Mild Alzheimer's disease (AD) defined by the combination of 1) at least mild cognitive impairment defined as a modified TICS score of ≤ 34, 2) informant-report of Instrumental Activities of Daily Living impairment as defined as a score of ≥ 6 on the NACC Functional Activities Questionnaire, and 3) a Clinical Dementia Rating score of 1.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Personalized tDCS will improve 6 primary outcomes and 10 secondary outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention.

Trail making test A-B
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
This metric assesses cognitive executive function.
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
Five-day accelerometry-based physical activity
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
This metric assesses the quantity and quality of habitual physical activity.
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
Dual task standing postural sway speed
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
This metric assesses the ability to control standing posture while performing a secondary cognitive task.
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
Dual task stride time variability
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
This metric assesses the ability to control gait while performing a secondary cognitive task.
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
Hopkins Verbal Learning Test
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
This common test assesses memory.
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
Category and Phonemic Fluency Test
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
This common test assesses word retrieval.
BASELINE, WITHIN 3 DAYS AFTER COMPLETION OF THE INTERVENTION, TWO WEEKS AFTER COMPLETING THE INTERVENTION
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Who is running the study

Principal Investigator
B. M.
Brad Manor, Assistant Scientist II; Director, Mobility and Brain Function Lab, Hinda and Arthur Marcus Institute for Aging Research
Hebrew SeniorLife

Patient Q & A Section

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

What is alzheimer disease?

The risk of developing AD rises with age. Alzheimer's disease is a progressive condition that can lead to severe disability or death. The first signs of AD may not be detectable until years after the onset of symptoms. This article and the Alzheimer's Society Website provide useful information about risk factors, symptoms, diagnosis and treatment of AD, and relevant news and support groups.

Anonymous Patient Answer

What are the signs of alzheimer disease?

Many signs and symptoms precede the diagnosis of Alzheimer disease. Early signs include aphasia, visual complaints, sleep problems, forgetfulness, irritability and hallucinations (a symptom of the disease). Symptoms may be vague, particularly if the disease is more advanced. For example, early symptoms such as forgetting people and things and not knowing where one is may lead to frustration and anger. The symptoms of Alzheimer's disease are variable; and symptoms may differ between individuals.

Anonymous Patient Answer

What causes alzheimer disease?

The risk of developing Alzheimer disease decreases with greater education and increases with earlier onset; in both groups, smoking has a positive effect on the risk and is a strong risk factor for men. The role of genetics is not large.

Anonymous Patient Answer

What are common treatments for alzheimer disease?

Many people with Alzheimer's disease rely on a caregiver or medical professionals for care, and many people also receive a prescription of an antidepressant in addition to cognitively stimulating therapies. There are many common medications to support the immune system but the main treatment for AD is cognitive behavior therapy or antidepressants. Older people with Alzheimer's disease often benefit from psychotherapy, and people with the more severe forms of AD are being provided with medications such as memantine and atypical antipsychotics in the hope they will slow cognitive decline. Treatment is highly variable among older people with Alzheimer's disease, but can include any of the above as well as behavioral interventions, a program of physical therapy in order to strengthen and maintain muscle, and some dietary supplementation.

Anonymous Patient Answer

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

In 2018, approximately 25 million Americans were already living with Alzheimer's disease and its related dementias. By 2050, however, the Alzheimer's Disease Association projected these numbers to rise to 76 million individuals.

Anonymous Patient Answer

Can alzheimer disease be cured?

Treatment of neuropsychiatric symptoms in AD will improve patient quality of life, but it is uncertain what role any single treatment will play in future disease progression or slowing down the disease process. In many respects, treatment of neuropsychiatric symptoms does not appear to alter disease progression. While some neuropsychiatric symptoms can be treated and might improve function, the dementia progresses and no evidence suggests they are halting disease progression. Until such data arrive however, the decision to treat must be individualized.

Anonymous Patient Answer

How does personalized tdcs work?

We conclude that personalized tDCS results in antidepressant effects and behavioral improvement in both sexes with severe depression without affecting cognitive and functional improvements. The effects of tDCS were associated with changes in connectivity of the fronto-cingulo-insular networks. The clinical utility of tDCS for treatment of depression appears promising.

Anonymous Patient Answer

Have there been any new discoveries for treating alzheimer disease?

There has not been a major shift in the way the disease is treated and understood. There has been progress in the development of clinical trials to test novel medications and neuroimaging methods. For both of these new techniques, the most crucial aspect has not changed: the patient population.

Anonymous Patient Answer

How serious can alzheimer disease be?

If untreated, this disease can reduce a person's ability to enjoy life, and it can affect a family's sense of security (https://www.nia.nih.gov/health/alzheimers-disease-fact-sheet#:~:text=The%20late%20stage%20of%20Alzheimer's%20disease). Many patients live more than 10 years with this disease: that means that it can take a long time to learn about the disorder, but it takes a lifetime to lose your ability to live.

Anonymous Patient Answer

What is personalized tdcs?

Data from a recent study have revealed that a personalized transcranial direct current stimulation protocol is a feasible therapeutic tool for mild-to-moderate depression. Therefore, our results should be used in clinical trials; however, we recommend more research be conducted on more patients and on longer time points.

Anonymous Patient Answer

Is personalized tdcs typically used in combination with any other treatments?

This analysis shows that for personalized transcranial direct current stimulation there is broad usage of such treatments in combination with other therapies, but we could not see any specific effect due to the use of one such treatment.

Anonymous Patient Answer

Does alzheimer disease run in families?

In a recent study, findings of this investigation do not support the hypothesis that AD has a genetic component and that a genetic basis must exist for the disease.

Anonymous Patient Answer
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