ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease (ADvance)
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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
:
Active, not recruiting
First Posted
: May 30, 2012
Last Update Posted
: February 16, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Device: DBS-f on Device: DBS-f off | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: DBS-f on
DBS-f on
|
Device: DBS-f on
deep brain stimulation of the fornix
Other Names:
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Sham Comparator: DBS-f off
DBS-f off
|
Device: DBS-f off
deep brain stimulation of the fornix turned off
Other Names:
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- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 45 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 45-85 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.

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
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 |
Principal Investigator: | Andres Lozano, MD, PhD | University Health Network, Toronto | |
Principal Investigator: | Constantine G Lyketsos, MD, MHS, DFAPA, FAPM | Johns Hopkins University |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Functional Neuromodulation Ltd |
ClinicalTrials.gov Identifier: | NCT01608061 History of Changes |
Other Study ID Numbers: |
FNMI-001 |
First Posted: | May 30, 2012 Key Record Dates |
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 |