Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease (ECP-EA)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03290274 |
Recruitment Status : Unknown
Verified August 2017 by Juan Antonio Barcia Albacar, Hospital San Carlos, Madrid.
Recruitment status was: Recruiting
First Posted : September 21, 2017
Last Update Posted : September 21, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Device: Deep brain stimulation (fornix) Device: Deep brain stimulation (Basal nucleus of Meynert) | Not Applicable |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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…)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290274
Contact: Aurora Viloria, MD | +34913003306 | mariaaurora.viloria@salud.madrid.org |
Spain | |
Hospital Clinico San Carlos | Recruiting |
Madrid, Spain | |
Contact: Aurora Viloria, MD +34913003306 mariaaurora.viloria@salud.madrid.org |
Principal Investigator: | Aurora Viloria, MD | Hospital Clinico San Carlos |
Responsible Party: | Juan Antonio Barcia Albacar, Head of Neurosurgery Department, Hospital San Carlos, Madrid |
ClinicalTrials.gov Identifier: | NCT03290274 |
Other Study ID Numbers: |
ECP-EA |
First Posted: | September 21, 2017 Key Record Dates |
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 |
Deep brain stimulation Alzheimer´s Disease Fornix Basal nucleus of Meynert |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |