NCT03959124

Deep Brain Stimulation for Alzheimer's Disease

Status unknown NA Last updated 17 July 2020

What this trial tests

NA trial testing Deep brain stimulation in Alzheimer Disease in 30 participants. Status unknown.

Timeline

6 April 2020

Primary endpoint
30 September 2020

30 September 2021

Quick facts

Lead sponsor	Buddhist Tzu Chi General Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	6 April 2020
Primary completion	30 September 2020
Estimated completion	30 September 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• Deep brain stimulation
• Best medical treatment for Alzheimer's disease — full drug profile →

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Dementia, Alzheimer Type — all drugs for Dementia, Alzheimer Type →
• Deep Brain Stimulation — all drugs for Deep Brain Stimulation →

Sponsor

Buddhist Tzu Chi General Hospital

Who can join

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

Sponsor's own description

Background: Deep brain stimulation (DBS) is used to modulate the activity of dysfunctional brain circuits. The safety and preliminary efficacy of nucleus basalis of Meynert (NBM)-DBS in Alzheimer's disease (AD) is proved in a recent phase 1 clinical trial, yet, the mechanism still unknown.

Objective: 1. To compare the brain structure and functional circuits between a) AD patients with optimal drug treatment (ODT) plus NBM-DBS, b) AD with ODT and c) normal age-and sex-matched control. 2. To evaluate the clinical effectiveness of NBM-DBS in AD patients 60-75 year-old. 3. To evaluate the abnormal functional circuitry response to acute and chronic NBM-DBS in AD.

Methods: A total of 30 subjects (10 subjects of AD with ODT plus NBM-DBS; 10 subjects of AD with ODT and 10 subjects of normal age-and sex-matched subjects) will be enrolled in this prospective, with normal control, Phase II study. Study tools will include clinical rating batteries, structure and functional imaging of magnetic resonance (MR) and positron emission tomography (PET), and electroencephalogram (EEG).

Expected Results: NBM-DBS will be proved to be an safe and effective treatment modality in AD patients 60-75 year-old. Through multi-modal images and EEG analysis, the possible action mechanisms of NBM-DBS on memory circuit will be discussed. The study results may shed a light on this helpless neurodegenerative disease of dementia.

Publications & conference data

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

1. 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
2. The Crosstalk Between Pathological Tau Phosphorylation and Mitochondrial Dysfunction as a Key to Understanding and Treating Alzheimer's Disease.
   Guha S, Johnson GVW, Nehrke K. · · 2020 · cited 40× · PMID 32851560 · DOI 10.1007/s12035-020-02084-0
3. Electrical stimulation of the nucleus basalis of meynert: a systematic review of preclinical and clinical data.
   Nazmuddin M, Philippens IHCHM, van Laar T. · · 2021 · cited 25× · PMID 34083732 · DOI 10.1038/s41598-021-91391-0
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 Combined with NMDA Antagonist Therapy in the Treatment of Alzheimer's Disease: In Silico Trials.
   Świetlik D. · · 2024 · PMID 39768683 · DOI 10.3390/jcm13247759