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



Status:Active, not recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:45 - 85
Updated:4/21/2016
Start Date:May 2012
End Date:September 2018

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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

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.


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.
We found this trial at
7
sites
Gainesville, Florida 32611
(352) 392-3261
University of Florida Gainesville UF has a long history of established programs in international education,...
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Baltimore, Maryland 21224
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Philadelphia, PA
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Phoenix, Arizona 85006
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69 Brown Street
Providence, Rhode Island 02912
(401) 863-1000
Brown University Located in historic Providence, Rhode Island and founded in 1764, Brown University is...
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Sun City, Arizona 85351
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Toronto, Ontario
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Toronto,
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