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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

Tracking Information
First Submitted Date  ICMJE May 21, 2012
First Posted Date  ICMJE May 30, 2012
Results First Submitted Date  ICMJE February 18, 2020
Results First Posted Date  ICMJE August 31, 2020
Last Update Posted Date August 31, 2020
Actual Study Start Date  ICMJE May 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: DBS-f on
    DBS-f on
    Intervention: Device: DBS-f on
  • Sham Comparator: DBS-f off
    DBS-f off
    Intervention: Device: DBS-f off
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2020)
42
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2012)
20
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01608061
Other Study ID Numbers  ICMJE FNMI-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Functional Neuromodulation Ltd
Study Sponsor  ICMJE Functional Neuromodulation Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andres Lozano, MD, PhD University Health Network, Toronto
Principal Investigator: Constantine G Lyketsos, MD, MHS, DFAPA, FAPM Johns Hopkins University
PRS Account Functional Neuromodulation Ltd
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP