Full‑immersive virtual reality cognitive training for people with mild to moderate dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project begins with a feasibility phase in which 10 participants will complete a single VR session and have feasibility and emotion-related measures recorded before and after. The efficacy phase is a randomized crossover trial planning to enroll about 30 participants to receive 15 training sessions, each 65 minutes long, delivered three times per week. Outcomes include a primary cognitive function measure and secondary outcomes such as activities of daily living, quality of life, emotion, and clinical symptoms. Within-subject comparisons across the crossover will be used to determine whether the VR leisure cognitive training produces measurable benefits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age over 55 years;
2. Diagnosed with mild or moderate dementia (primarily degenerative dementia) by a consulting physician or based on past medical records;
3. A score of at least 11 but no more than 23 on the Mini-Mental State Examination (MMSE);
4. Has at least one family member or a regularly contacted friend (with the person's mobile number and contact at least once a week);
5. Able to walk independently and complete the Timed Up \& Go (TUG) test;
6. Able to follow instructions with or without the assistance of a guardian or therapist;
7. If the assessment indicates moderate dementia, further evaluation will be conducted to determine whether the participant has sufficient capacity to provide informed consent. If their capacity is found to be impaired, the study will be explained to their legal representative

Exclusion Criteria:

1. Dementia with Lewy Bodies and other dementia types resulting from specific causes, such as Huntington's Disease, substance addiction, central nervous system infections, nutritional deficiencies, and metabolic disorders.
2. Severe health conditions that may hinder safe participation, such as respiratory distress, severe cardiovascular disease, or brain tumors.
3. A psychiatric diagnosis of psychosis within the past six months.
4. Diagnosis of Korsakoff syndrome.
5. History of substance addiction.
6. Severe hearing impairment or color blindness.
7. History of severe vertigo or epilepsy.
8. Concurrent participation in other studies that may affect cognitive function

Where it's running

• Tucheng Hospital, New Taipei City, commissioned and operated by Chang Gung Medical Foundation.
  New Taipei City, Taiwan Recruiting

Study contacts

• Principal investigator: Ching-yi Wu, ScD — Chang Gung Memorial Hospital
• Study coordinator: Ching-yi Wu, ScD
• Email: cywu@mail.cgu.edu.tw
• Phone: #886-3-2118800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.