N/A
N=42
ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT01608061 ↗Enrolled (actual)
42
Serious AEs
38.1%
Results posted
Aug 2020
Primary outcome: Primary: Acute Safety — 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DBS-f on (Device); DBS-f off (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Functional Neuromodulation Ltd
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Safety |
2 | — |
| PRIMARY Long Term Safety. Not Based on Formal Hypotheses. |
0; 1 | — |
| SECONDARY ADAS-Cog 13 |
8.0; 8.0 | — |
| SECONDARY CDR-SB |
2.5; 2.6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01608061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.