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NCT03290274: ECP-EA
Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease
NA trial testing Deep brain stimulation (fornix) in Alzheimer Disease in 6 participants. Status unknown.
1 December 2019
Quick facts
| Lead sponsor | Hospital San Carlos, Madrid |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 1 March 2017 |
| Primary completion | 1 December 2019 |
| Estimated completion | 1 December 2019 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Deep brain stimulation (fornix)
- Deep brain stimulation (Basal nucleus of Meynert)
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
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):
-
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03290274
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03290274 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital San Carlos, Madrid
- Last refreshed: 21 September 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03290274.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing