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

San Carlos Clinical Hospital

Status: Unknown

Conditions: Alzheimer Disease

Treatments: Device: Deep brain stimulation (Basal nucleus of Meynert); Device: Deep brain stimulation (fornix)

Study type: Interventional

Funder types: Other

Identifiers

NCT03290274

ECP-EA

Details and patient eligibility

About

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).

Enrollment: 6 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 2 patient groups

Deep brain stimulation (fornix)

Experimental group

Description:

Deep brain stimulation at fornix area

Treatment:

Device: Deep brain stimulation (fornix)

Deep brain stimulation (Basal nucleus of Meynert)

Experimental group

Description:

Deep brain stimulation at Basal nucleus of Meynert

Treatment:

Device: Deep brain stimulation (Basal nucleus of Meynert)