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Procedure
DBS for Alzheimer's Disease
N/A
Waitlist Available
Research Sponsored by Functional Neuromodulation Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 65 years old
ADAS-cog-11 score of 10-24 inclusive at screening AND baseline (with a score ≥ 4 on ADAS-cog item 1).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will test if a brain stimulator can help treat Alzheimer's by measuring changes in the patients' symptoms over time.
Who is the study for?
This trial is for individuals at least 65 years old with mild Alzheimer's Disease, confirmed by specific criteria and CSF biomarkers. Participants must be fluent in the test language, have a caregiver, and either take stable Alzheimer's medication or have documented reasons not to. They should be good candidates for deep brain stimulator surgery but can't join if they have certain cardiovascular issues, psychiatric disorders, high stroke risk scores, or are involved in other clinical trials.Check my eligibility
What is being tested?
The ADvance II Study is testing whether turning on deep brain stimulation (DBS-f) slows down cognitive decline in Alzheimer's patients compared to no stimulation. The effect of DBS-f will be measured over a year using an integrated rating scale that assesses both cognitive and functional abilities.See study design
What are the potential side effects?
While the side effects aren't detailed here, typical risks associated with deep brain stimulation may include headache, confusion, difficulty concentrating, mood changes, and surgical complications like infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 years old or older.
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My memory test score is between 10 and 24, showing some memory issues.
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I have been diagnosed with Alzheimer's disease.
Select...
I have been diagnosed with Alzheimer's disease.
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My memory test score is between 10 and 24, showing some memory issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline Over Time at 12 months on the Ingegrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: From Baseline to month 12 ]
Secondary outcome measures
Change From Baseline Over Time at 12 months on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [ Time Frame: From Baseline to month 12 ]
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DBS OnExperimental Treatment1 Intervention
DBS system On
Group II: DBS OffPlacebo Group1 Intervention
DBS System Off
Find a Location
Who is running the clinical trial?
Functional Neuromodulation LtdLead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your Alzheimer's disease has been confirmed using specific spinal fluid tests.I haven't been exposed to high levels of radiation in the last year.I do not have heart or brain vessel problems that would stop me from joining the study.My doctor and I decided against cholinesterase inhibitors for my treatment, and this is documented.You have mild memory and thinking problems according to a test called the Clinical Dementia Rating.The surgical team approves me for deep brain stimulator surgery.You have significant neuropsychiatric symptoms or high levels of apathy.Your score on the Modified Hachinski Ischemia Scale is higher than 4 during screening.I have been on a steady dose of Alzheimer's medication for at least 60 days.You had a bad reaction or the medication didn't work for you before, and the dose won't change during the study.I am 65 years old or older.My memory test score is between 10 and 24, showing some memory issues.I have had a brain tumor, subdural hematoma, or significant brain lesion.I am not currently using, nor plan to use, any amyloid-beta drugs like aducanumab within a year after joining this study.The surgical team considers me a good candidate for deep brain stimulator surgery.I have been diagnosed with Alzheimer's disease.You cannot have an MRI scan because you have metal implants or feel very uncomfortable in small, enclosed spaces.Being able to fluently speak and write the language in which the standardized tests will be administered is important.This criterion is incomplete. Please provide the full text of the criterion so that I can accurately summarize it for you.If the doctor or you think you might harm yourself, or if you recently tried to harm yourself, you cannot participate.You are expected to live for less than one year.I have been diagnosed with Alzheimer's disease.I am not on any medications that would stop me from joining the study.You have a serious mental illness like schizophrenia, bipolar disorder, or major depression, or you are currently abusing alcohol or drugs according to a mental health evaluation.You had a serious head injury within the two years before agreeing to join the study.I have a history of seizures.You have mild dementia as determined by a specific rating scale.My memory test score is between 10 and 24, showing some memory issues.
Research Study Groups:
This trial has the following groups:- Group 1: DBS On
- Group 2: DBS Off
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT03622905 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many distinct venues are involved in conducting this research?
"The University of Nebraska Medical Center in Omaha, Barrow Neurological Institute in Phoenix and the University of Texas Health Sciences Centre at San Antonio are among 15 clinical trial sites that have been approved for this medical research."
Answered by AI
Is this clinical trial recruiting participants at present?
"According to the data available on clinicaltrials.gov, this trial is actively enrolling participants and was originally posted in August 2019 with its latest update taking place in September 2022."
Answered by AI
What is the total participant count for this experiment?
"To fulfil the requirements of this medical trial, 210 candidates are sought who meet specified inclusionary criteria. These individuals have the choice to partake in this research from various locales such as University of Nebraska Medical Center in Omaha or Barrow Neurological Institute located in Phoenix."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Florida
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
University of Florida
Rhode Island Hospital
Why did patients apply to this trial?
My Father had it and I'm thinking I might also have it. My mom died of cognitive impairment related causes and I am very interested in caring for my own cognitive health when thinking about how heredity plays into the picture.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do screening visits take?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
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