At a glance
ClinicalIndex Comparison RecordN/ACompleted· 42 enrolled
Drug / intervention
DBS-f on +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating DBS-f on and DBS-f off for Alzheimer Disease. Completed, enrolled 42 participants across 7 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2012
First PostedMay 2012
Primary CompletionJun 2015
Study CompletionSep 2018
TodayJul 2026
First PostedMay 30, 2012
Enrollment StartMay 1, 2012
Primary CompletionJun 1, 2015
Study CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.1 years ago
Interventions
DBS-f ondevice
deep brain stimulation of the fornix
DBS-f offdevice
deep brain stimulation of the fornix turned off