ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease
NCT ID: NCT01608061
Last Updated: 2020-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2012-05-31
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DBS-f on
DBS-f on
DBS-f on
deep brain stimulation of the fornix
DBS-f off
DBS-f off
DBS-f off
deep brain stimulation of the fornix turned off
Interventions
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DBS-f on
deep brain stimulation of the fornix
DBS-f off
deep brain stimulation of the fornix turned off
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria.
3. Must meet certain criteria on cognitive and behavioral rating scales
4. If female, subjects who are post-menopausal or surgically sterile or willing to use birth control methods for the duration of the study.
5. An available caregiver willing to participate.
6. Subject is living at home and likely to remain at home for the study duration.
7. The subject is currently taking a stable dose of cholinesterase inhibitor (AChEI) medication for at least 60 days
Exclusion Criteria
2. Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit
3. History of head trauma in the 2 years prior to signing the consent to participate in the study
4. History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI
5. Active psychiatric disorder
6. Mental retardation
7. Current alcohol or substance abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
8. Contraindications for PET scanning (e.g., insulin dependent diabetes)
9. 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.
10. Abnormal lab results that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
11. Abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
12. Unstable doses of any medication prescribed for the treatment of memory loss or Alzheimer's disease.
13. Currently prescribed any non-AD medications that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
14. Is unable or unwilling to comply with protocol follow-up requirements.
15. Has a life expectancy of \< 1 year.
16. Is actively enrolled in another concurrent clinical trial.
45 Years
85 Years
ALL
No
Sponsors
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Functional Neuromodulation Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Andres Lozano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Constantine G Lyketsos, MD, MHS, DFAPA, FAPM
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Banner Research Institute at Sun City
Sun City, Arizona, United States
University of Florida at Gainesville
Gainesville, Florida, United States
Johns Hopkins Bayview
Baltimore, Maryland, United States
Hospital of the University of Pennsylvania: Penn Memory Clinic
Philadelphia, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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References
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Lozano AM, Fosdick L, Chakravarty MM, Leoutsakos JM, Munro C, Oh E, Drake KE, Lyman CH, Rosenberg PB, Anderson WS, Tang-Wai DF, Pendergrass JC, Salloway S, Asaad WF, Ponce FA, Burke A, Sabbagh M, Wolk DA, Baltuch G, Okun MS, Foote KD, McAndrews MP, Giacobbe P, Targum SD, Lyketsos CG, Smith GS. A Phase II Study of Fornix Deep Brain Stimulation in Mild Alzheimer's Disease. J Alzheimers Dis. 2016 Sep 6;54(2):777-87. doi: 10.3233/JAD-160017.
Ponce FA, Asaad WF, Foote KD, Anderson WS, Rees Cosgrove G, Baltuch GH, Beasley K, Reymers DE, Oh ES, Targum SD, Smith GS, Lyketsos CG, Lozano AM; ADvance Research Group. Bilateral deep brain stimulation of the fornix for Alzheimer's disease: surgical safety in the ADvance trial. J Neurosurg. 2016 Jul;125(1):75-84. doi: 10.3171/2015.6.JNS15716. Epub 2015 Dec 18.
Related Links
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Study Informational Website
Other Identifiers
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FNMI-001
Identifier Type: -
Identifier Source: org_study_id
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