ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease (ADvance)

Study Description

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Brief Summary:

The primary objective of this feasibility study is to evaluate the safety of DBS-f in patients with mild Alzheimer's disease by assessing all device and/or therapy related adverse events. The secondary objective is to preliminarily estimate the treatment effect size on the outcomes of interest at 12 months post-randomization. The objectives do not involve formal tests of hypotheses.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease	Device: DBS-f on; Device: DBS-f off	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Twelve Month Double-blind Randomized Controlled Feasibility Study to Evaluate the Safety, Efficacy and Tolerability of Deep Brain Stimulation of the Fornix (DBS-f) in Patients With Mild Probable Alzheimer's Disease
Study Start Date :	May 2012
Actual Primary Completion Date :	June 2015
Estimated Study Completion Date :	September 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: DBS-f on; DBS-f on	Device: DBS-f on; deep brain stimulation of the fornix; Other Names: DBS-f system includes:; *Medtronic Activa PC Model 37601 Implantable Neurostimulator (INS); *Medtronic Model 3387 DBS Lead; *Medtronic Model 37085 DBS Extension Kit; *Medtronic Model 3708660 DBS Extension Kit
Sham Comparator: DBS-f off; DBS-f off	Device: DBS-f off; deep brain stimulation of the fornix turned off; Other Names: DBS-f system includes:; *Medtronic Activa PC Model 37601 Implantable Neurostimulator (INS); *Medtronic Model 3387 DBS Lead; *Medtronic Model 37085 DBS Extension Kit; *Medtronic Model 3708660 DBS Extension Kit

Outcome Measures

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Primary Outcome Measures :

1. The study will assess the acute and long-term safety of the system. A detailed assessment of all device and/or therapy related adverse events will be conducted. [ Time Frame: 12 month ]

Secondary Outcome Measures :

1. Efficacy outcomes include: improvement in ADAS-cog 13 at twelve months, improvement in the CDR and changes in glucose metabolism measured by FDG-PET at twelve months [ Time Frame: twelve months ]

Eligibility Criteria

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Ages Eligible for Study:	45 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. 45-85 years of age (inclusive)
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:

1. Must meet certain criteria on cognitive and behavioral rating scales
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.

Contacts and Locations

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Locations

United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Banner Research Institute at Sun City
Sun City, Arizona, United States, 85351
United States, Florida
University of Florida at Gainesville
Gainesville, Florida, United States, 32607
United States, Maryland
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224
United States, Pennsylvania
Hospital of the University of Pennsylvania: Penn Memory Clinic
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02906
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8

Sponsors and Collaborators

Functional Neuromodulation Ltd

Investigators

Principal Investigator:	Andres Lozano, MD, PhD	University Health Network, Toronto
Principal Investigator:	Constantine G Lyketsos, MD, MHS, DFAPA, FAPM	Johns Hopkins University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Study Informational Website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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; for The 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.

Responsible Party:	Functional Neuromodulation Ltd
ClinicalTrials.gov Identifier:	NCT01608061 History of Changes
Other Study ID Numbers:	FNMI-001
First Posted:	May 30, 2012
Last Update Posted:	February 16, 2017
Last Verified:	February 2017

Keywords provided by Functional Neuromodulation Ltd:

Mild probable Alzheimer's Disease

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders