Status:
COMPLETED
Deep Brain Stimulation in Alzheimer's Disease: Biomarkers and Dose Optimization
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Alzheimer Disease
Eligibility:
All Genders
45-85 years
Phase:
NA
Brief Summary
Title: Deep Brain Stimulation of the Fornix in Alzheimer's Disease: Investigating clinical and imaging biomarkers and dose optimization Objective: To evaluate the influence of deep brain stimulatio...
Detailed Description
Background/Rationale: Despite years of recognition and attempts at treatment, Alzheimer's Disease (AD) remains a pervasive and challenging condition, with an inexorable progression to severe disabili...
Eligibility Criteria
Inclusion
- Informed consent signed by the subject AND a reliable caregiver
- 45-85 years of age (inclusive)
- Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria.
- Clinical Dementia Rating (CDR) global rating of 0.5 or 1 at screening.
- ADAS-cog-11 score of 12-30 inclusive at screening AND baseline (with a score ≥ 4 on ADAS-cog item 1) or a Mini Mental State Examination (MMSE) of 16-28.
- If female, post-menopausal, surgically sterile or willing to use birth control methods for the duration of the study.
- 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 is living at home and likely to remain at home for the study duration.
- General Medical Health Rating (GMHR) ≥ 3 (good or excellent general health).
- 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 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 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 length of study participation).
Exclusion
- Neuropsychiatric Inventory (NPI) total score ≥ 10 or score ≥ 4 in any NPI domain (clinically significant neuropsychiatric symptoms). Apathy score ≥ 4 acceptable.
- Subjects 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 time of evaluation) at the screening or baseline visit.
- Cornell Scale for Depression and Dementia (CSDD) score \> 10 at the screening visit
- Young Mania Rating Scale (YMRS) ≥ 11 at the screening visit
- Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit
- The subject has attempted suicide in the 2 years prior to signing the consent to participate in the study.
- In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study
- History of head trauma 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
- Active psychiatric disorder
- Mental retardation
- Current alcohol or substance abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Contraindications for PET scanning (e.g., insulin dependent diabetes)
- 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 lab results that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
- Abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
- Unstable dose of any medication prescribed for the treatment of memory loss or Alzheimer's disease.
- Currently prescribed any non-AD medications that, in the opinion of the investigator and/or enrollment review committee, 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.
Key Trial Info
Start Date :
December 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04856072
Start Date
December 19 2014
End Date
December 5 2023
Last Update
December 5 2023
Active Locations (1)
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1
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8