Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT07033468
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT07033468
Study Brief:
Protocol Section:
NCT07033468