Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease

Alzheimer Disease Clinical Trial

— ECP-EA  

Official title:

Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03290274
• Other study ID #: ECP-EA
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2017
• Last updated: September 19, 2017
• Start date: March 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2017
• Source: Hospital San Carlos, Madrid
• Contact: Aurora Viloria, MD
• Phone: +34913003306
• Email: mariaaurora.viloria[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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 Aß 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…)

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• Deep brain stimulation (fornix)
Deep brain stimulation at fornix
• Deep brain stimulation (Basal nucleus of Meynert)
Deep brain stimulation AT Basal nucleus of Meynert

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Security	Determinate number of adverse event in each group such as infections, hospitalization, epilepsia, bleeding or hemiparesis	2 years