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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03290274

Acronym

ECP-EA

Enrollment

Registered

2017-09-21

Start date

2017-03-01

Completion date

2019-12-01

Last updated

2017-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

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

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).

Interventions

DEVICEDeep brain stimulation (fornix)

Deep brain stimulation at fornix

DEVICEDeep brain stimulation (Basal nucleus of Meynert)

Deep brain stimulation AT Basal nucleus of Meynert

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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…)

Design outcomes

Primary

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

Countries

Spain

Contacts

Primary ContactAurora Viloria, MD

mariaaurora.viloria@salud.madrid.org+34913003306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026