ADvance II Study: DBS-f in Patients With Mild Alzheimer's Disease

  • STATUS
    Recruiting
  • sponsor
    Functional Neuromodulation
Updated on 22 November 2021
dementia
alzheimer's disease
donepezil
cholinesterase inhibitors
rivastigmine
galantamine
cholinesterase
mild dementia

Summary

ADvance II: A 12-month Double-blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Deep Brain Stimulation of the Fornix (DBS-f) in Patients With Mild Probable Alzheimer's Disease

Description


Details
Condition memory, alzheimer's disease, memory problems, Memory Loss, Memory Loss, Alzheimer, Alzheimer's Disease, neurology, Dementia, ADvance II Study: DBS-f in Patients With Mild Alzheimer's Disease, Dementia, Alzheimers, Mild Cognitive Impairment, Alzheimer's, alzheimers disease, dementia study, ADvance II Study for mild Alzheimer's Disease
Clinical Study IdentifierTX287866
SponsorFunctional Neuromodulation
Last Modified on22 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed consent signed by the subject and caregiver
At least 65 years old
Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria
Mild dementia according to the Clinical Dementia Rating (CDR) global rating of 0.5 or 1 at screening
ADAS-cog-11 score of 10-24 inclusive at screening AND baseline (with a score ≥ 4 on ADAS-cog item 1)
Confirmation of Alzheimer's disease based on CSF biomarkers
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
Patient must be a good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team
Fluency (oral and written) in the language in which standardized tests will be administered
The patient is either a.) 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 b.) 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 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

NPI total score ≥ 10 or score ≥ 4 in any NPI domain (clinically significant neuropsychiatric symptoms). Apathy score ≥ 4 acceptable
Modified Hachinski ischemia scale score > 4 at screening
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
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
History of moderate or more severe traumatic brain injury in the 2 years prior to signing the consent to participate in the study
History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI
History of seizure disorder
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
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
Abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator would preclude participation in the study
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
Currently prescribed any non-AD medications that, in the opinion of the investigator would preclude participation in the study
Is unable or unwilling to comply with protocol follow-up requirements
Has a life expectancy of < 1 year
Is actively enrolled in another concurrent clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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