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:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT07284316
Eligibility Criteria:
Inclusion Criteria:
* Minimum Age: 55 Years Maximum Age: 70 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No Criteria: Inclusion criteria.
1. With 55-70 years of age.
2. They have self-reported cognitive concerns (ie, have answered "yes" to the question: "Do you feel like your memory or thinking skills have gotten worse recently?").
3. The participant has insulin resistance measured with HOMA IR index \> 2.5.
4. They demonstrate functional independence in activities of daily living and instrumental activities of daily living.
5. They have symptoms or signs of underlying cognitive dysfunction without a diagnosis of dementia (ie, confirmed by a review of their health records and a Mini Mental State Exam \[MMSE\] score\> 24).
6. If the participant are a woman, one year after having gone through menopause.
Exclusion Criteria:
\- 1. With depression (score\> 15 according to the Center for Epidemiological Studies Depression Scale - Revised \[CESD-R\]). 2. With clinically significant neurological or psychiatric disorders (eg, Parkinson's, schizophrenia). 3. With a recent severe cardiovascular event (eg, myocardial infarction, stroke). 4. With a major orthopedic condition (eg, severe osteoarthritis). 5. With blood pressure that is unsafe for exercise (ie,\> 180/100 mmHg or \<100/60 mmHg). 6. With a severe visual or auditory impairment. 7. With an unwillingness to adhere to the intervention schedules. 8. Patients with active cancer, who are undergoing chemotherapy, radiotherapy, or other treatments aimed at eradicating cancer and who have been undergoing treatment during the last year.
9\. Elimination: participants with incomplete data and who have not complied with the intervention by 80%.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT07284316
Study Brief:
Protocol Section:
NCT07284316