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NCT03290274: ECP-EA

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

Status unknown NA Last updated 21 September 2017
What this trial tests

NA trial testing Deep brain stimulation (fornix) in Alzheimer Disease in 6 participants. Status unknown.

Timeline
1 March 2017
Primary endpoint
1 December 2019
1 December 2019

Quick facts

Lead sponsorHospital San Carlos, Madrid
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment6
Start date1 March 2017
Primary completion1 December 2019
Estimated completion1 December 2019
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Hospital San Carlos, Madrid

Who can join

Adults 50 to 80, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Alzheimer's disease drug development pipeline: 2019.
    Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
  2. Treatment Combinations for Alzheimer's Disease: Current and Future Pharmacotherapy Options.
    Cummings JL, Tong G, Ballard C. · · 2019 · cited 371× · PMID 30689575 · DOI 10.3233/jad-180766
  3. A circuit view of deep brain stimulation in Alzheimer's disease and the possible mechanisms.
    Yu D, Yan H, Zhou J, Yang X, et al · · 2019 · cited 34× · PMID 31395077 · DOI 10.1186/s13024-019-0334-4
  4. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
    Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
  5. Opening the debate on deep brain stimulation for Alzheimer disease - a critical evaluation of rationale, shortcomings, and ethical justification.
    Bittlinger M, Müller S. · · 2018 · cited 13× · PMID 29886845 · DOI 10.1186/s12910-018-0275-4
  6. Directional DBS of the Fornix in Alzheimer's Disease Achieves Long-Term Benefits: A Case Report.
    Barcia JA, Viloria MA, Yubero R, Sanchez-Sanchez-Rojas L, et al · · 2022 · cited 5× · PMID 35431895 · DOI 10.3389/fnagi.2022.809972

Verify or expand the search:

Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

Other Hospital San Carlos, Madrid trials

Trials by the same sponsor.

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