Overview

This trial is active, not recruiting.

Condition alzheimer disease
Treatments dbs-f on, dbs-f off
Phase phase 1/phase 2
Sponsor Functional Neuromodulation Ltd
Start date May 2012
End date June 2015
Trial size 50 participants
Trial identifier NCT01608061, FNMI-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
DBS-f on
dbs-f on DBS-f system includes:
deep brain stimulation of the fornix
(Sham Comparator)
DBS-f off
dbs-f off DBS-f system includes:
deep brain stimulation of the fornix turned off

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 45 years up to 85 years old.

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.

Additional Information

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
Principal investigator Andres Lozano, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Functional Neuromodulation Ltd.