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

September 19, 2017 updated by: Juan Antonio Barcia Albacar, Hospital San Carlos, Madrid
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Security
Time Frame: 2 years
Determinate number of adverse event in each group such as infections, hospitalization, epilepsia, bleeding or hemiparesis
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

Investigators

  • Principal Investigator: Aurora Viloria, MD, Hospital Clinico San Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (ACTUAL)

September 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECP-EA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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