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

Completed · Not applicable

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT01608061

Run by

Functional Neuromodulation Ltd

People needed

42

Starts

2012-05-01

Expected to finish

2018-09-01

Last updated by the study team

2020-08-31

Who can join

Age: 45 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• Banner Research Institute at Sun City — Sun City, Arizona, United States
• University of Florida at Gainesville — Gainesville, Florida, United States
• Johns Hopkins Bayview — Baltimore, Maryland, United States
• Hospital of the University of Pennsylvania: Penn Memory Clinic — Philadelphia, Pennsylvania, United States
• Brown University — Providence, Rhode Island, United States
• Toronto Western Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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