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A Phase II Study of Fornix Deep Brain Stimulation in Mild Alzheimer's Disease.

ABSTRACT: Deep brain stimulation (DBS) is used to modulate the activity of dysfunctional brain circuits. The safety and efficacy of DBS in dementia is unknown.To assess DBS of memory circuits as a treatment for patients with mild Alzheimer's disease (AD).We evaluated active "on" versus sham "off" bilateral DBS directed at the fornix-a major fiber bundle in the brain's memory circuit-in a randomized, double-blind trial (ClinicalTrials.gov NCT01608061) in 42 patients with mild AD. We measured cognitive function and cerebral glucose metabolism up to 12 months post-implantation.Surgery and electrical stimulation were safe and well tolerated. There were no significant differences in the primary cognitive outcomes (ADAS-Cog 13, CDR-SB) in the "on" versus "off" stimulation group at 12 months for the whole cohort. Patients receiving stimulation showed increased metabolism at 6 months but this was not significant at 12 months. On post-hoc analysis, there was a significant interaction between age and treatment outcome: in contrast to patients?<65 years old (n?=?12) whose results trended toward being worse with DBS ON versus OFF, in patients?65 (n?=?30) DBS-f ON treatment was associated with a trend toward both benefit on clinical outcomes and a greater increase in cerebral glucose metabolism.DBS for AD was safe and associated with increased cerebral glucose metabolism. There were no differences in cognitive outcomes for participants as a whole, but participants aged?65 years may have derived benefit while there was possible worsening in patients below age 65 years with stimulation.

SUBMITTER: Lozano AM

PROVIDER: S-EPMC5026133 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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A Phase II Study of Fornix Deep Brain Stimulation in Mild Alzheimer's Disease.

Lozano Andres M AM Fosdick Lisa L Chakravarty M Mallar MM Leoutsakos Jeannie-Marie JM Munro Cynthia C Oh Esther E Drake Kristen E KE Lyman Christopher H CH Rosenberg Paul B PB Anderson William S WS Tang-Wai David F DF Pendergrass Jo Cara JC Salloway Stephen S Asaad Wael F WF Ponce Francisco A FA Burke Anna A Sabbagh Marwan M Wolk David A DA Baltuch Gordon G Okun Michael S MS Foote Kelly D KD McAndrews Mary Pat MP Giacobbe Peter P Targum Steven D SD Lyketsos Constantine G CG Smith Gwenn S GS

Journal of Alzheimer's disease : JAD 20160901 2

<h4>Background</h4>Deep brain stimulation (DBS) is used to modulate the activity of dysfunctional brain circuits. The safety and efficacy of DBS in dementia is unknown.<h4>Objective</h4>To assess DBS of memory circuits as a treatment for patients with mild Alzheimer's disease (AD).<h4>Methods</h4>We evaluated active "on" versus sham "off" bilateral DBS directed at the fornix-a major fiber bundle in the brain's memory circuit-in a randomized, double-blind trial (ClinicalTrials.gov NCT01608061) in ...[more]

PMID: 27567810

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Project description:OBJECT This report describes the stereotactic technique, hospitalization, and 90-day perioperative safety of bilateral deep brain stimulation (DBS) of the fornix in patients who underwent DBS for the treatment of mild, probable Alzheimer's disease (AD). METHODS The ADvance Trial is a multicenter, 12-month, double-blind, randomized, controlled feasibility study being conducted to evaluate the safety, efficacy, and tolerability of DBS of the fornix in patients with mild, probable AD. Intraoperative and perioperative data were collected prospectively. All patients underwent postoperative MRI. Stereotactic analyses were performed in a blinded fashion by a single surgeon. Adverse events (AEs) were reported to an independent clinical events committee and adjudicated to determine the relationship between the AE and the study procedure. RESULTS Between June 6, 2012, and April 28, 2014, a total of 42 patients with mild, probable AD were treated with bilateral fornix DBS (mean age 68.2 ± 7.8 years; range 48.0-79.7 years; 23 men and 19 women). The mean planned target coordinates were x = 5.2 ± 1.0 mm (range 3.0-7.9 mm), y = 9.6 ± 0.9 mm (range 8.0-11.6 mm), z = -7.5 ± 1.2 mm (range -5.4 to -10.0 mm), and the mean postoperative stereotactic radial error on MRI was 1.5 ± 1.0 mm (range 0.2-4.0 mm). The mean length of hospitalization was 1.4 ± 0.8 days. Twenty-six (61.9%) patients experienced 64 AEs related to the study procedure, of which 7 were serious AEs experienced by 5 patients (11.9%). Four (9.5%) patients required return to surgery: 2 patients for explantation due to infection, 1 patient for lead repositioning, and 1 patient for chronic subdural hematoma. No patients experienced neurological deficits as a result of the study, and no deaths were reported. CONCLUSIONS Accurate targeting of DBS to the fornix without direct injury to it is feasible across surgeons and treatment centers. At 90 days after surgery, bilateral fornix DBS was well tolerated by patients with mild, probable AD. Clinical trial registration no.: NCT01608061 ( clinicaltrials.gov ).

Dataset Information

A Phase II Study of Fornix Deep Brain Stimulation in Mild Alzheimer's Disease.

Publications

A Phase II Study of Fornix Deep Brain Stimulation in Mild Alzheimer's Disease.

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