Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease (ECP-EA)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Approximately one million of Spaniards suffer from AlzhEimer´s Disease (AD) and this figure is expected to triple by 20150. The approved treatments modulate neurotransmission in general and are not specific or anatomically directed. In AD there is a dysfunction in cognitive and memory circuits. It has been shown that the deep brain stimulation (DBS) can specially modulate circuits in such a way that is modulable, and this approach is safe. The safety of this treatment and its biological effects are convincing enough to require further study of possible therapeutic effects of DBS in AD. The objectives are: To evaluate the security of DBS in AD (main objective). To study the influence of DBS in the progress of AD, to compare the effects of DBS on the brain metabolism neural connectivity and hubs using MEG, and to compare the effects between two different groups: fornix and Basal nucleus of Meynert (BNM). To achieve this, a prospective, double-blind comparison study between groups will be conducted, to evaluate the effects of DBS in 6 patients: group I (fornix) and group II ( BNM).

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease	Device: Deep brain stimulation (fornix); Device: Deep brain stimulation (Basal nucleus of Meynert)	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	6 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease
Actual Study Start Date :	March 1, 2017
Estimated Primary Completion Date :	December 1, 2019
Estimated Study Completion Date :	December 1, 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Deep brain stimulation (fornix); Deep brain stimulation at fornix area	Device: Deep brain stimulation (fornix); Deep brain stimulation at fornix
Experimental: Deep brain stimulation (Basal nucleus of Meynert); Deep brain stimulation at Basal nucleus of Meynert	Device: Deep brain stimulation (Basal nucleus of Meynert); Deep brain stimulation AT Basal nucleus of Meynert

Outcome Measures

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Primary Outcome Measures :

1. Security [ Time Frame: 2 years ]
   Determinate number of adverse event in each group such as infections, hospitalization, epilepsia, bleeding or hemiparesis

Eligibility Criteria

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Ages Eligible for Study:	50 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Age: Between 50-80 years old
• Diagnosis criteria of Alzheimer disease (Dubois criteria) in the previous 2 years
• Presence of tau, p-tau or Aβ in cerebrospinal fluid or positive amiloid-PET scan
• Clinical dementia rating scale (CDR): 1
• Use of cholinesterase inhibitors and/or memantine during one year at least, and worsening in neuropsychologic tests in spite of the treatment
• Informed consent (patient and caregiver or legal representative)

Exclusion Criteria:

• Brain structural disorders: primary or metastatic tumor, Hydrocephalus, stroke, brain abscess or cerebral malformation
• Vascular dementia (NINCDS-AIREN criteria)
• Neurodegenerative disease other than AD
• Psychiatric disease
• Epilepsy
• Severe or unstable comorbidity (mellitus diabetes, high blood pressure…)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Aurora Viloria, MD	+34913003306	mariaaurora.viloria@salud.madrid.org

Locations

Spain
Hospital Clinico San Carlos	Recruiting
Madrid, Spain
Contact: Aurora Viloria, MD +34913003306 mariaaurora.viloria@salud.madrid.org

Sponsors and Collaborators

Hospital San Carlos, Madrid

Investigators

Principal Investigator:	Aurora Viloria, MD	Hospital Clinico San Carlos

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Juan Antonio Barcia Albacar, Head of Neurosurgery Department, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:	NCT03290274 History of Changes
Other Study ID Numbers:	ECP-EA
First Posted:	September 21, 2017
Last Update Posted:	September 21, 2017
Last Verified:	August 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Juan Antonio Barcia Albacar, Hospital San Carlos, Madrid:

Deep brain stimulation; Alzheimer´s Disease; Fornix; Basal nucleus of Meynert

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders