Deep Brain Stimulation for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Toronto Western Hospital, University Health Network, Toronto, Canada
Alzheimer Disease
Deep Brain Stimulation - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether deep brain stimulation can improve cognitive function in people with Alzheimer's disease.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Deep Brain Stimulation will improve 5 primary outcomes, 3 secondary outcomes, and 4 other outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Baseline, Post-Operative Months 6, 12.

Month 3
Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory 23-item Scale (ADCS-ADL23)
Hopkins Verbal Learning Test (HVLT)
Visual Association Memory Test
Month 6
Change in Cerebrospinal fluid (CSF) biomarkers for Alzheimer's disease
Change in MRI scan
Change in PET scan
Month 1
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Month 3
Change in Clinical Dementia Rating (CDR) Scale
Columbia Suicide Severity Rating Scale (C-SSRS)
Cornell Scale for Depression in Dementia (CSDD)
Neuropsychiatric Inventory (NPI)
Young Mania Rating Scale (YMRS)

Trial Safety

Side Effects for

Deep Brain Stimulation
Fall
23%
Depression
15%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
8%
Speech disorder
5%
Influenza
5%
Tremor
5%
Dystonia
5%
Head injury
5%
Gait disturbance
5%
Skeletal injury
5%
Paraesthesia
5%
Urinary tract infection
5%
Back pain
5%
Dyspepsia
5%
Panic attack
3%
Diabetes mellitus
3%
Rib fracture
3%
Insomnia
3%
Joint sprain
3%
Respiratory depression
3%
Pain in extremity
3%
Bursitis
3%
Axillary pain
3%
Anxiety
3%
Depressed mood
3%
Bronchitis
3%
Cyst
3%
Hypertension
3%
Hypotension
3%
Parkinson's disease
3%
Device migration
3%
Pneumonia
3%
Cystitis
3%
Akinesia
3%
Localised infection
3%
Skin laceration
3%
Syncope
3%
Staphylococcal infection
3%
Implant site infection
3%
Helicobacter gastritis
3%
Nerve root lesion
3%
Rapid eye movements sleep abnormal
3%
Fibula fracture
3%
Alcohol poisoning
3%
Thermal burn
3%
Adverse drug reaction
3%
Urinary incontinence
3%
Movement disorder
3%
Cerebral microangiopathy
3%
Hypoaesthesia
3%
Contusion
3%
Dysarthria
3%
Memory impairment
3%
Sciatica
3%
Anger
3%
Confusional state
3%
Incision site infection
3%
Postoperative wound infection
3%
Fluid retention
3%
Ear infection
3%
Intervertebral disc protrusion
3%
Arthralgia
3%
Cough
3%
Pleural effusion
3%
Spinal osteoarthritis
3%
Implant site haematoma
3%
Hallucination, auditory
3%
Impulse-control disorder
3%
Neck pain
3%
Drug withdrawal syndrome
3%
Seborrhoeic keratosis
3%
Folate deficiency
3%
Pericardial effusion
3%
Monarthritis
3%
Oedema peripheral
3%
Laboratory test abnormal
3%
Osteoarthritis
3%
Pyrexia
3%
Diplopia
3%
Ingrowing nail
3%
Weight increased
3%
Productive cough
3%
Macular degeneration
3%
Thrombophlebitis
3%
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01221948) in the Deep Brain Stimulation ARM group. Side effects include: Fall with 23%, Depression with 15%, Hand fracture with 8%, Restless legs syndrome with 8%, Apathy with 8%.

Trial Design

1 Treatment Group

Treatment
1 of 1
Experimental Treatment

This trial requires 12 total participants across 1 different treatment group

This trial involves a single treatment. Deep Brain Stimulation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Treatment
Device
All patients will be implanted with a deep brain stimulation system and will receive personalized fornix stimulation; parameters will be selected based on the dose finding cognitive tests.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~340

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: screening, baseline, post-operative months 1, 3, 6, 9, 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly screening, baseline, post-operative months 1, 3, 6, 9, 12 for reporting.

Who is running the study

Principal Investigator
A. M. L.
Andres M. Lozano, Neurosurgeon
University Health Network, Toronto

Closest Location

Toronto Western Hospital, University Health Network - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People aged from 45 to 85 years old. show original
The individual has a significant impairment in memory and at least one other cognitive domain, with gradual onset and progressive course. show original
The patient must have a score of 12-30 on the ADAS-cog-11 test at screening AND a score of 4 or more on the ADAS-cog item 1 at baseline OR a score of 16-28 on the MMSE. show original
The patient needs an available caregiver or other appropriate knowledgeable informant to help report on their daily activities and function show original
The person has good or excellent general health. show original
The subject signs an informed consent, and a reliable caregiver witness this. show original
If you are a woman who has gone through menopause, is surgically sterile, or is willing to use birth control methods for the duration of the study, then you may be eligible to participate in this study. show original
The patient must be judged to be a good candidate for surgery to implant a deep brain stimulator by the surgical team involved in the procedure. show original
The person has a slight or mild level of dementia if their CDR global rating is 0.5 or 1. show original
The patient is living at home and is likely to remain at home for the study duration. show original

Patient Q&A Section

Can alzheimer disease be cured?

"There is considerable variation in the efficacy of treatments for AD; the majority of this variability reflects differences in the disease pathology, rather than differences in treatment effect. Data from a recent study imply that the only reasonable expectation for any AD treatment is that it will improve some aspect of cognitive or behavioral deficits in some individuals." - Anonymous Online Contributor

Unverified Answer

What are the signs of alzheimer disease?

"It is difficult to determine the exact date of onset of AD, but a rapid decline in cognitive function, memory impairment and behavioural changes (such as irritability, mood swings or aggression) are typical signs.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for alzheimer disease?

"Antihormones are commonly given to help with dementia because dementia is commonly caused by Alzheimer's disease. Antihormones are not the only treatment but it also helps to control the Alzheimer's disease like in the brain. Neurotransmitters may also have some effect of dementia." - Anonymous Online Contributor

Unverified Answer

What causes alzheimer disease?

"Factors associated with the development of Alzheimer disease include age, age at onset, gender, family history, cognition, education, and genetics, but these factors do not make up the full picture. The cause may relate to the process of brain aging from normal and normal-aging, or it may be that the process of aging itself results in the development of Alzheimer's disease." - Anonymous Online Contributor

Unverified Answer

What is alzheimer disease?

"Currently there are no cure for Alzheimer disease despite several years of intensive research. A disease that destroys such an integral portion of our daily lives can only be treated to an extent. Alzheimer's can cause significant financial hardship and loss for those caring for them. Patients, families, and friends of sufferers can experience great emotional pain while trying to cope under the debilitating disability that is Alzheimer's disease. As we delve into the future of Alzheimer's there are several avenues to explore in order to find treatments that could halt the disease or possibly cure it. There is still a great deal of information to gather before any therapeutic methods or remedies could be implemented. The most reliable method of information acquisition is through trial and error and ongoing research." - Anonymous Online Contributor

Unverified Answer

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

"In 2003 and 2004, the combined estimate of cases of Alzheimer disease and related dementias (AD+PD, AD+DP, AD+VF, and ARD) was 394,873, accounting for 2.4% and 2.0% of the population, aged 65 and over, respectively. In 2010, the combined estimate of diagnoses of Alzheimer disease a year was 41,900, accounting for 2.6% of the population 65 and over." - Anonymous Online Contributor

Unverified Answer

Is deep brain stimulation typically used in combination with any other treatments?

"Of the 3 types of DBS, subperiosteal DBS appears to be most effective and less invasively (without exposing the brain to high-dose radiation) and is associated with higher rates of seizure freedom, with the most common side effects being nausea and dizziness, whereas subcaudal DBS was associated with highest rates of complications. Further investigation is needed to determine the efficacy and incidence of complications in all indications of DBS, including subcaudal DBS." - Anonymous Online Contributor

Unverified Answer

How does deep brain stimulation work?

"This review provides a framework for understanding DBS as a therapeutic agent, incorporating current knowledge of its mechanisms of action. This framework highlights specific brain regions important in DBS as a therapy, and provides useful guidance for practitioners. This review also highlights a number of areas where DBS may be improved, which should be considered as we advance our understanding of the cellular mechanisms of DBS." - Anonymous Online Contributor

Unverified Answer

How serious can alzheimer disease be?

"Results from a recent paper of our study suggest that older adults with mild AD may develop complications from minor fractures and major health issues. In contrast, the results of our study suggest that older adults with moderate AD should not be over- or underestimated because they may have a high likelihood of experiencing serious consequences." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for alzheimer disease?

"Most patients need additional treatment beyond what they are receiving as part of their care and for the majority of them there would be a likelihood of being cured by clinical trials. Physicians and patients should consider all aspects of the potential benefits and risks before making a decision about clinical trials." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving deep brain stimulation?

"The current article was derived from a previous abstract that was presented at an FDA meeting. Further clinical trials and meta-analyses will be warranted to establish the efficacy and safety of DBS in treating symptoms such as psychosis, depression or dystonia." - Anonymous Online Contributor

Unverified Answer

Has deep brain stimulation proven to be more effective than a placebo?

"Results from a recent clinical trial of the present study showed that the DBS of the subcallosal gyrus does not increase the efficacy of antipsychotic drug treatment in patients suffering from drug resistant AD. But it may slightly reduce the severity of motor symptoms in some." - Anonymous Online Contributor

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