NCT03290274

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 21, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

September 13, 2017

Last Update Submit

September 19, 2017

Conditions

Alzheimer Disease

Keywords

Deep brain stimulationAlzheimer´s DiseaseFornixBasal nucleus of Meynert

Outcome Measures

Primary Outcomes (1)

  • Security

    Determinate number of adverse event in each group such as infections, hospitalization, epilepsia, bleeding or hemiparesis

    2 years

Study Arms (2)

Deep brain stimulation (fornix)

EXPERIMENTAL

Deep brain stimulation at fornix area

Device: Deep brain stimulation (fornix)

Deep brain stimulation (Basal nucleus of Meynert)

EXPERIMENTAL

Deep brain stimulation at Basal nucleus of Meynert

Device: Deep brain stimulation (Basal nucleus of Meynert)

Interventions

Deep brain stimulation (fornix)DEVICE

Deep brain stimulation at fornix

Deep brain stimulation (fornix)
Deep brain stimulation (Basal nucleus of Meynert)DEVICE

Deep brain stimulation AT Basal nucleus of Meynert

Deep brain stimulation (Basal nucleus of Meynert)

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Spain

RECRUITING

Related Publications (1)

  • Barcia JA, Viloria MA, Yubero R, Sanchez-Sanchez-Rojas L, Lopez A, Strange BA, Cabrera M, Canuet L, Gil P, Nombela C. Directional DBS of the Fornix in Alzheimer's Disease Achieves Long-Term Benefits: A Case Report. Front Aging Neurosci. 2022 Apr 1;14:809972. doi: 10.3389/fnagi.2022.809972. eCollection 2022.

    PMID: 35431895DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Aurora Viloria, MD

    Hospital Clinico San Carlos

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurora Viloria, MD

CONTACT

+34913003306mariaaurora.viloria@salud.madrid.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurosurgery Department

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 21, 2017

Study Start

March 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 21, 2017

Record last verified: 2017-08

Locations

ES(1)