Status:
UNKNOWN
Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease
Lead Sponsor:
Hospital San Carlos, Madrid
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-80 years
Phase:
NA
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 sp...
Eligibility Criteria
Inclusion
- 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
- 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…)
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03290274
Start Date
March 1 2017
End Date
December 1 2019
Last Update
September 21 2017
Active Locations (1)
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1
Hospital Clinico San Carlos
Madrid, Spain