ADvance II Study: DBS-f in Patients With Mild Alzheimer's Disease
NCT ID: NCT03622905
Last Updated: 2024-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2019-08-01
2024-02-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DBS On
DBS system On
DBS-f On
Deep Brain Stimulation of the fornix
DBS Off
DBS System Off
DBS Off
Deep Brain Stimulation of the fornix turned off
Interventions
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DBS-f On
Deep Brain Stimulation of the fornix
DBS Off
Deep Brain Stimulation of the fornix turned off
Eligibility Criteria
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Inclusion Criteria
2. At least 65 years old
3. Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria.
4. Mild dementia according to the Clinical Dementia Rating (CDR) global rating of 0.5 or 1 at screening.
5. ADAS-cog-11 score of 10-24 inclusive at screening AND baseline (with a score ≥ 4 on ADAS-cog item 1).
6. Confirmation of Alzheimer's disease based on CSF biomarkers.
7. The patient has an available caregiver or other appropriate knowledgeable informant who can reliably report on daily activities and function and signs the informed consent for participation as such.
8. Patient must be a good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team.
9. Fluency (oral and written) in the language in which standardized tests will be administered.
10. The patient is either
1. taking a stable dose of cholinesterase inhibitor (AChEI) medication (donepezil, galantamine, or rivastigmine) for at least 60 days prior to signing the informed consent form OR
2. the patient has previously had an intolerance/failure to cholinesterase inhibitor medications that can be documented AND there is no intention to modify the dose over the course of the study (NOTE: These medications may NOT be initiated, discontinued or modified during the 12-month control period).
OR
3. c) a physician has fully discussed the possibility of prescribing cholinesterase inhibitors and the physician in collaboration with the patient/caregiver have declined trying cholinesterase inhibitors and this discussion and decision are fully documented in the patient's medical records. This discussion occurred during the course of the patient's care, and not as a component of enrollment or discussion of participation in this clinical trial.
AND there is no intention to modify the dose over the course of the study (NOTE: These medications may NOT be initiated, discontinued or modified after study initiation for the 12-months control period).
Exclusion Criteria
2. Modified Hachinski ischemia scale score \> 4 at screening.
3. At risk for suicide in the opinion of the investigator or the subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at the time of evaluation) at the screening visit or attempted suicide within the last 2 years.
4. Suffers from a major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder, or has current alcohol or substance abuse based on psychiatric consultation at screening visit.
5. History of moderate or more severe traumatic brain injury in the 2 years prior to signing the consent to participate in the study.
6. History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI.
7. History of seizure disorder.
8. Contraindications for MRI scanning, including implanted metallic devices (e.g. non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces.
9. Radiation exposure in the 1 year prior to signing the informed consent form that, in combination with the radiation exposure from this study, would exceed 5 rem.
10. Abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator would preclude participation in the study.
11. Currently prescribed or planning to start any amyloid-beta directed antibody drug (e.g. aducanumab or similar) within the first year following implantation in this study. Prior use of amyloid-beta directed antibody drugs must be stopped at least 6 months prior to signing consent.
12. Currently prescribed any non-AD medications that, in the opinion of the investigator would preclude participation in the study.
13. Is unable or unwilling to comply with protocol follow-up requirements.
14. Has a life expectancy of \< 1 year.
15. Is actively enrolled in another concurrent clinical trial.
65 Years
ALL
No
Sponsors
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Functional Neuromodulation Ltd
INDUSTRY
Responsible Party
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Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Stanford University
Stanford, California, United States
University of Florida
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Saint Louis University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Texas
Austin, Texas, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, United States
Toronto Western Hospital
Toronto, Ontario, Canada
Universitätmedizin Charité Berlin
Berlin, , Germany
Universitätklinikum Köln
Cologne, , Germany
Universitätsklinikum Schleswig Holstein Campus
Kiel, , Germany
Universität Magdeburg
Magdeburg, , Germany
Technische Universität München
Munich, , Germany
Universitätsklinikum München: Klinik und Poliklinik für Psychiatrie und Psychotherapie Alzheimer Therapie- und Forschungszentrum
München, , Germany
Universitätklinikum Würzburg
Würzburg, , Germany
Countries
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Other Identifiers
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FNMI-002
Identifier Type: -
Identifier Source: org_study_id