NCT03920826

Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease (TRANSFORM-AD)

Completed NA Last updated 18 October 2022

What this trial tests

NA trial testing transcranial alternating current stimulation in Alzheimer Disease in 46 participants. Completed in 15 April 2022.

Timeline

11 September 2019

Primary endpoint
15 January 2022

15 April 2022

Quick facts

Lead sponsor	Xuanwu Hospital, Beijing
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	46
Start date	11 September 2019
Primary completion	15 January 2022
Estimated completion	15 April 2022
Sites	1 location across China

Drugs / interventions tested

• transcranial alternating current stimulation
• sham stimulation

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Xuanwu Hospital, Beijing

Who can join

Adults 45 to 75, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this study is to explore the efficacy and safety of transcranial alternating current stimulation (tACS) in patients with mild Alzheimer's disease (AD). The study will recruit 40 individuals with mild AD with evidence of amyloid plaques in the brain through Positron Emission Tomography (PET) imaging. Participants will undergo baseline cognitive assessment, structural and functional MRI characterization, PiB-PET, and resting-state EEG measurement. The participants will be randomized to either a tACS group or a sham stimulation group. At the end of the intervention and 3-month follow-up, all subjects will repeat the baseline assessments.

Publications & conference data

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

1. Modulation of Brain Hyperexcitability: Potential New Therapeutic Approaches in Alzheimer's Disease.
   Toniolo S, Sen A, Husain M. · · 2020 · cited 74× · PMID 33297460 · DOI 10.3390/ijms21239318
2. 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
3. Cognitive and Neuropathophysiological Outcomes of Gamma-tACS in Dementia: A Systematic Review.
   Manippa V, Palmisano A, Nitsche MA, Filardi M, et al · · 2024 · cited 37× · PMID 36877327 · DOI 10.1007/s11065-023-09589-0
4. Transcranial alternating current stimulation (tACS) at gamma frequency: an up-and-coming tool to modify the progression of Alzheimer's Disease.
   De Paolis ML, Paoletti I, Zaccone C, Capone F, et al · · 2024 · cited 17× · PMID 38926897 · DOI 10.1186/s40035-024-00423-y
5. TRanscranial AlterNating current stimulation FOR patients with mild Alzheimer's Disease (TRANSFORM-AD): a randomized controlled clinical trial.
   Tang Y, Xing Y, Sun L, Wang Z, et al · · 2024 · cited 15× · PMID 39267112 · DOI 10.1186/s13195-024-01570-0
6. TRanscranial AlterNating current Stimulation FOR patients with Mild Alzheimer's Disease (TRANSFORM-AD study): Protocol for a randomized controlled clinical trial.
   Xing Y, Wei P, Wang C, Shan Y, et al · · 2020 · cited 14× · PMID 32313830 · DOI 10.1002/trc2.12005
7. Modulation of Cortical and Hippocampal Functional MRI Connectivity Following Transcranial Alternating Current Stimulation in Mild Alzheimer Disease.
   Wang T, Yan S, Shan Y, Xue H, et al · · 2025 · cited 7× · PMID 40552996 · DOI 10.1148/radiol.241463
8. Altered Neuronal Activity Patterns of the Prefrontal Cortex in Alzheimer's Disease After Transcranial Alternating Current Stimulation: A Resting-State fMRI Study.
   Wang T, Yan S, Shan Y, Xing Y, et al · · 2024 · cited 2× · PMID 39269839 · DOI 10.3233/jad-240400