NCT03622905

ADvance II Study: DBS-f in Patients With Mild Alzheimer's Disease

Completed NA Last updated 5 November 2024

What this trial tests

NA trial testing DBS-f On in Alzheimer Disease in 74 participants. Completed in 19 February 2024.

Timeline

1 August 2019

Primary endpoint
19 February 2024

19 February 2024

Quick facts

Lead sponsor	Functional Neuromodulation Ltd
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	74
Start date	1 August 2019
Primary completion	19 February 2024
Estimated completion	19 February 2024
Sites	21 locations across Canada, United States, Germany

Drugs / interventions tested

• DBS-f On
• DBS Off

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Functional Neuromodulation Ltd

Who can join

65 and older, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary efficacy objective of this study is to test the hypothesis that DBS-f stimulation (ON) will slow cognitive and functional progression of AD, as compared to no stimulation (OFF), by measuring baseline (pre-implantation) to 12-month change in the integrated Alzheimer's disease rating scale (iADRS).

Publications & conference data

8 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. Optimal deep brain stimulation sites and networks for stimulation of the fornix in Alzheimer's disease.
   Ríos AS, Oxenford S, Neudorfer C, Butenko K, et al · · 2022 · cited 66× · PMID 36517479 · DOI 10.1038/s41467-022-34510-3
3. Therapy for Alzheimer's disease: Missing targets and functional markers?
   Stoiljkovic M, Horvath TL, Hajós M. · · 2021 · cited 52× · PMID 33711510 · DOI 10.1016/j.arr.2021.101318
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. Deep brain stimulation for the treatment of Alzheimer's disease: A systematic review and meta-analysis.
   Majdi A, Deng Z, Sadigh-Eteghad S, De Vloo P, et al · · 2023 · cited 14× · PMID 37123370 · DOI 10.3389/fnins.2023.1154180
6. Applications of Endovascular Brain-Computer Interface in Patients with Alzheimer's Disease.
   Sun Y, Chen D, Ye Q, You Z, et al · · 2025 · cited 1× · PMID 41446876 · DOI 10.34133/research.1049
7. The Potential for Neuromodulation in the Treatment of Alzheimer's Disease: A Review of Clinical Trials.
   Jones T, Shalom M, Chalamgari A, Gold J, et al · · 2025 · PMID 40599507 · DOI 10.7759/cureus.85156
8. Activity-dependent mechanisms of neuroprotection: promising avenues against dementia.
   Tampellini D. · · 2024 · PMID 38051871 · DOI 10.4103/1673-5374.387985