ADvance II Study: DBS-f in Patients With Mild Alzheimer's Disease

ADvance II: A 12-month Double-blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Deep Brain Stimulation of the Fornix (DBS-f) in Patients With Mild Probable Alzheimer's Disease

Patrocinadores

Patrocinador principal: Functional Neuromodulation Ltd

Fuente Functional Neuromodulation Ltd
Resumen breve

The primary efficacy objective of this study is to test the hypothesis that DBS-f stimulation (ON) will slow cognitive and functional progression of AD, as compared to no stimulation (OFF), by measuring baseline (pre-implantation) to 12-month change in the integrated Alzheimer's disease rating scale (iADRS).

Estado general Recruiting
Fecha de inicio August 1, 2019
Fecha de Terminación October 1, 2024
Fecha de finalización primaria October 1, 2023
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change From Baseline Over Time at 12 months on the Ingegrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: From Baseline to month 12 ] 12 months
Resultado secundario
Medida Periodo de tiempo
Change From Baseline Over Time at 12 months on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [ Time Frame: From Baseline to month 12 ] 12 months
Inscripción 210
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: DBS-f On

Descripción: Deep Brain Stimulation of the fornix

Etiqueta de grupo de brazo: DBS On

Tipo de intervención: Device

Nombre de intervención: DBS Off

Descripción: Deep Brain Stimulation of the fornix turned off

Etiqueta de grupo de brazo: DBS Off

Elegibilidad

Criterios:

Inclusion Criteria:

1. Informed consent signed by the subject and caregiver.

2. At least 65 years old

3. Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria.

4. Mild dementia according to the Clinical Dementia Rating (CDR) global rating of 0.5 or 1 at screening.

5. ADAS-cog-11 score of 10-24 inclusive at screening AND baseline (with a score ≥ 4 on ADAS-cog item 1).

6. Confirmation of Alzheimer's disease based on CSF biomarkers.

7. The patient has an available caregiver or other appropriate knowledgeable informant who can reliably report on daily activities and function and signs the informed consent for participation as such.

8. Patient must be a good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team.

9. Fluency (oral and written) in the language in which standardized tests will be administered.

10. The patient is either

1. taking a stable dose of cholinesterase inhibitor (AChEI) medication (donepezil, galantamine, or rivastigmine) for at least 60 days prior to signing the informed consent form OR

2. the patient has previously had an intolerance/failure to cholinesterase inhibitor medications that can be documented AND there is no intention to modify the dose over the course of the study (NOTE: These medications may NOT be initiated, discontinued or modified during the 12-month control period).

Exclusion Criteria:

1. NPI total score ≥ 10 or score ≥ 4 in any NPI domain (clinically significant neuropsychiatric symptoms). Apathy score ≥ 4 acceptable.

2. Modified Hachinski ischemia scale score > 4 at screening.

3. At risk for suicide in the opinion of the investigator or the subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at the time of evaluation) at the screening visit or attempted suicide within the last 2 years.

4. Suffers from a major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder, or has current alcohol or substance abuse based on psychiatric consultation at screening visit.

5. History of moderate or more severe traumatic brain injury in the 2 years prior to signing the consent to participate in the study.

6. History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI.

7. History of seizure disorder.

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. Radiation exposure in the 1 year prior to signing the informed consent form that, in combination with the radiation exposure from this study, would exceed 5 rem.

11. Abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator would preclude participation in the study.

12. Currently prescribed any non-AD medications that, in the opinion of the investigator would preclude participation in the study.

13. Is unable or unwilling to comply with protocol follow-up requirements.

14. Has a life expectancy of < 1 year.

15. Is actively enrolled in another concurrent clinical trial.

Género: All

Edad mínima: 65 Years

Edad máxima: N/A

Voluntarios Saludables: No

Contacto general

Apellido: Kristen Drake

Teléfono: 214-543-8321

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Investigador:
Barrow Neurological Institute | Phoenix, Arizona, 85013, United States Recruiting Margeaux Snell 800-392-2222 Anna Burke, MD Principal Investigator
University of Southern California | Los Angeles, California, 90033, United States Recruiting Sandra Oviedo 323-865-9873 [email protected] Darrin Lee, MD Principal Investigator
Stanford University | Stanford, California, 94305, United States Recruiting Vyvian Ngo 650-498-0817 [email protected] Casey Halpern, MD Principal Investigator
University of Florida | Gainesville, Florida, 32601, United States Recruiting Camille Swartz 352-273-5612 [email protected] Adolfo Ramirez, MD Principal Investigator
University of South Florida | Tampa, Florida, 33613, United States Recruiting Julie Samson 813-974-1201 [email protected] Jean Fils, MD Principal Investigator
Johns Hopkins University | Baltimore, Maryland, 21224, United States Recruiting John Kim 410-550-4696 [email protected] Paul Rosenberg, MD Principal Investigator
Wake Forest Baptist Health | Winston-Salem, North Carolina, 27157, United States Recruiting Wendy Jenkins 336-716-3842 [email protected] Adrian Laxton, MD Principal Investigator
Rhode Island Hospital | Providence, Rhode Island, 02903, United States Recruiting Karina Bertsch 401-793-9177 [email protected] Wael Asaad, MD, PhD Principal Investigator
University of Texas | Austin, Texas, 78712, United States Recruiting Ashleigh Smith 512-270-9039 [email protected] Robert Buchanan, MD Principal Investigator
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States Recruiting Karen Schmidt, RN 414-955-0674 [email protected] Malgorzata Franczak, MD Principal Investigator
Toronto Western Hospital | Toronto, Ontario, Canada Recruiting Martha Lenis, BHA (416) 603-5800 2797 [email protected] Andres Lozano, MD, PhD, FRCSC Principal Investigator
Universitätmedizin Charité Berlin | Berlin, Germany Recruiting Claudia Altendorf 004930450660226 [email protected] Andrea Kühn, M.D. Principal Investigator
Universitätklinikum Köln | Cologne, Germany Recruiting Elfriede Stubbs 0049-221-47898842 [email protected] Veere Visser-Vandewalle, M.D. Principal Investigator
Klinik für Neurologie Universitätsklinikum | Kiel, Germany Recruiting Birte Hackelberg 0049-431-50023989 [email protected] Steffen Paschen, M.D. Principal Investigator
Universität Magdeburg | Magdeburg, Germany Recruiting Urte Schneider 0049-391-6724601 [email protected] Jürgen Voges, M.D. Principal Investigator
Technische Universität München | Munich, Germany Recruiting Friederike Schels 00498941404276 [email protected] Timo Grimmer, M.D. Principal Investigator
Universitätklinikum Würzburg | Würzburg, Germany Recruiting Anne-Marie Ilita 0049-931-20124805 [email protected] Cordula Matthies, M.D. Principal Investigator
Ubicacion Paises

Canada

Germany

United States

Fecha de verificación

July 2020

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: DBS On

Tipo: Experimental

Descripción: DBS system On

Etiqueta: DBS Off

Tipo: Sham Comparator

Descripción: DBS System Off

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov