Trial · NCT05331560
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Global Cognition | Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up | Global cognition measured using the Hong Kong Chinese version of the Montreal Cognitive Assessment (HK-MoCA) is our primary outcome. The total score ranges from 0-30 with higher scores indicating better cognition. |
| Secondary | Changes in Verbal Fluency | Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up | Measured by the category verbal fluency test. |
| Secondary | Change in Working Memory | Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up | Measured by forward and backward digit span test. |
| Secondary | Change in Executive Functioning | Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up | Measured by the Trail Making Test Parts A and B. |
| Secondary | Change in Attention | Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up | Measured by the Stroop test. |
| Secondary | Change in Depressive Symptoms | Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up | Depressive symptoms will be assessed by the HAM-D-17, which is a widely used and reliable measure of depressive symptoms. Scores range from 0 to 52, with higher scores indicating more severe depression. |
| Secondary | Change in Daily Functioning | Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up | Instrumental activities of daily living will be assessed with the Hong Kong Chinese version of the Lawton Instrumental Activities of Daily Living Scale. |
| Secondary | Change in Apathy | Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up | The severity of apathy will be measured using the Hong Kong version of the Apathy Evaluation Scale (AES-HK) (in press, abstract). The AES-HK is an 18-item scale designed to measure apathy as a neuropsychiatric symptom. It is the most psychometrically sound measure of apathy across some disease populations. The internal consistency of the AES-HK was estimated using Cronbach's alpha, which yielded a coefficient of 0.946. The inter-rater and test-retest reliability were both satisfactory. |
| Secondary | Change in Adverse Effects and Risk Indicators | Across 6 TPS Treatment sessions | A checklist of potential adverse effects associated with TPS administration will be generated from the available literature on AD. The checklist will be used to monitor tolerability and adverse events in each session throughout the intervention. |
| Secondary | Changes in Brain Regional Volume Differences and White Matter Hyperintensities (WMH) | Baseline, 12-week Follow-up | Participants will receive pre and post treatment MRI scan to measure any changes in structural and functional connectivity changes in the brain. Structural MRI scans including T1- and T2-weighted fluid attenuation inversion recovery (T2-FLAIR) sequences, and Diffusion tensor imaging (DTI) will be used for assessing regional volume differences and WMH across the whole brain. |
| Secondary | Change in Brain Functional Connectivity | Baseline, 12-week Follow-up | Participants will receive pre and post treatment MRI scan to measure any changes in structural and functional connectivity changes in the brain. Resting-state fMRI of 150 T2-weighted gradient echo planar imaging (EPI) will be acquired, during which subjects will view a fixation cross ('+') passively at the centre of the screen. All resting state-fMRI (rs-fMRI) volumes will be pre-processed, with motion correction, slice timing correction, then linearly registered to the Montreal Neurological Institute (MNI) standard space. |
| Secondary | Change in Brain-Derived Neurotrophic Factor (BDNF) | Baseline, Immediate after 2-week TPS Treatment | A 20 ml venous blood sample will be collected from all participants before and after the TPS intervention to examine Brain-derived neurotrophic factor (BDNF). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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