ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease
This study is currently recruiting participants.
Verified May 2013 by Functional Neuromodulation Ltd
Sponsor:
Functional Neuromodulation Ltd
Information provided by (Responsible Party):
Functional Neuromodulation Ltd
ClinicalTrials.gov Identifier:
NCT01608061
First received: May 21, 2012
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Device: DBS-f on Device: DBS-f off |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Functional Neuromodulation Ltd:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DBS-f on
DBS-f on
|
Device: DBS-f on
deep brain stimulation of the fornix
Other Names:
|
|
Sham Comparator: DBS-f off
DBS-f off
|
Device: DBS-f off
deep brain stimulation of the fornix turned off
Other Names:
|
Eligibility| Ages Eligible for Study: | 55 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 55-80 years of age (inclusive)
- Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria.
- Must meet certain criteria on cognitive and behavioral rating scales
- If female, subjects who are post-menopausal or surgically sterile or willing to use birth control methods for the duration of the study.
- An available caregiver willing to participate.
- Subject is living at home and likely to remain at home for the study duration.
- The subject is currently taking a stable dose of cholinesterase inhibitor (AChEI) medication for at least 60 days
Exclusion Criteria:
- Must meet certain criteria on cognitive and behavioral rating scales
- Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit
- 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.
- 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 doses 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608061
Contacts
| Contact: Kristen Drake | (214) 543-8321 | kdrake@fxneuromod.com |
Locations
| United States, Arizona | |
| Banner Alzheimer's Institute | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Contact: Stephanie Reeder, BA 866-840-5838 BAIinfo@bannerhealth.com | |
| Principal Investigator: Anna Burke, MD | |
| Sub-Investigator: Francisco A Ponce, MD | |
| Banner Research Institute at Sun City | Recruiting |
| Sun City, Arizona, United States, 85351 | |
| Contact: Monika Sawdy 623-832-6512 monika.sawdy@bannerhealth.com | |
| Principal Investigator: Marwan Sabbagh, MD | |
| Sub-Investigator: Francisco A Ponce, MD | |
| United States, Florida | |
| University of Florida at Gainesville | Recruiting |
| Gainesville, Florida, United States, 32607 | |
| Contact: Stacy Merritt 352-273-5614 stacy.merritt@neurology.ufl.edu | |
| Principal Investigator: Michael Okun, M.D. | |
| Sub-Investigator: Kelly Foote, MD | |
| United States, Maryland | |
| Johns Hopkins Bayview | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Jane Pollutra, RN 410-550-4258 Jpollut1@jhmi.edu | |
| Sub-Investigator: Paul B Rosenberg, MD | |
| Principal Investigator: Constantine Lyketsos, MD | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania: Penn Memory Clinic | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jessica Nunez 215-662-4379 jessica.nunez@uphs.upenn.edu | |
| Principal Investigator: David Wolk, MD | |
| Sub-Investigator: Gordon H Baltuch, MD | |
| United States, Rhode Island | |
| Brown University | Recruiting |
| Providence, Rhode Island, United States, 02906 | |
| Contact: Diane Monast 401-455-6403 dmonast@butler.org | |
| Principal Investigator: Stephen P Salloway, MD | |
| Sub-Investigator: G. Rees Cosgrove, MD | |
| Canada, Ontario | |
| Toronto Western Hospital | Recruiting |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Contact: Karen Ng (416) 603-5800 ext 3304 Karenwy.ng@uhnresearch.ca | |
| Principal Investigator: Andres Lozano, MD, PhD | |
| Sub-Investigator: David Tang-Wai, MDCM FRCPC | |
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
Additional Information:
No publications provided
| Responsible Party: | Functional Neuromodulation Ltd |
| ClinicalTrials.gov Identifier: | NCT01608061 History of Changes |
| Other Study ID Numbers: | FNMI-001 |
| Study First Received: | May 21, 2012 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
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 Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013