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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01608061
Recruitment Status : Completed
First Posted : May 30, 2012
Results First Posted : August 31, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Functional Neuromodulation Ltd

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)
Actual Enrollment : 42 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
Actual Study Start Date : May 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


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. Acute Safety [ Time Frame: 30 days post implant ]
    Acute safety will be assessed by estimating the rate of serious device (pulse generator or lead) or procedure related adverse events from the date of implant through the date of randomization, plus serious procedure related events through 30 days post-implant. All subjects undergoing an implant procedure will be included in these rate estimates. The rate and 95% confidence interval will be presented. Analysis is of a timepoint prior to randomization and thus all subjects are analyzed together.

  2. Long Term Safety. Not Based on Formal Hypotheses. [ Time Frame: 12 month ]
    Long-term safety will be assessed by the rate of serious device or therapy related adverse events from the date of randomization through the date of the Month 12 visit. The rate and 95% confidence interval will be presented by randomization group. All subjects randomized will be included.


Secondary Outcome Measures :
  1. ADAS-Cog 13 [ Time Frame: Baseline and 12 months ]

    The mean change from baseline (pre-implant) to 12 months will be calculated in each treatment group. The differences between randomized groups in mean change will be calculated, along with corresponding 2-sided, 95% confidence intervals.

    Instrument is Alzheimer's Disease Assessment Scale - Cognitive subscale. Scores range from 0 to 85 with higher scores meaning worse outcome.


  2. CDR-SB [ Time Frame: Baseline and 12 months ]

    The mean change from baseline (pre-implant) to 12 months will be calculated in each treatment group. The differences between randomized groups in mean change will be calculated, along with corresponding 2-sided, 95% confidence intervals.

    The scale used is the Clinical Dementia Rating Scale and the score used is the sum of boxes. The scores for this measure range from 0 to 18 with a higher score indicating a worse outcome.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608061


Locations
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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
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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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Additional Information:

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

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Responsible Party: Functional Neuromodulation Ltd
ClinicalTrials.gov Identifier: NCT01608061    
Other Study ID Numbers: FNMI-001
First Posted: May 30, 2012    Key Record Dates
Results First Posted: August 31, 2020
Last Update Posted: August 31, 2020
Last Verified: August 2020
Keywords provided by Functional Neuromodulation Ltd:
Mild probable Alzheimer's Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders