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 @ 5:51 PM
Ignite Modification Date:
2025-12-24 @ 5:51 PM
NCT ID:
NCT01637168
Eligibility Criteria:
Inclusion Criteria:
1. Patients of any race, sex, aged 18-60 years;
2. Patients presenting two or more symptoms associated with disorders of cognitive function such as memory impairment, poor concentration, depressed mood, decreased mental capacity, provided they score value is below 24 in the evaluation of the psychometric test (Mini Test-mental and WMS-R Logical Memory);
3. Consent of the patient (Signature of the IC);
4. Patients are able to read and write;
5. "Washout" of at least two weeks of the start of the study, in case of use of multivitamins or any other medication for symptomatic treatment of disorders of cognitive function.
6. Women of childbearing potential must submit βHCG negative serum;
7. Patients are able to understand and carry out the study procedures;
Exclusion Criteria:
1. Patients with hypersensitivity to the components of the formula;
2. Patients who are making use of levodopa or salicylates;
3. Routine use of medications that alter cognitive functions such as barbiturates, anticonvulsants, benzodiazepines, neuroleptics, alcohol and illicit drugs;
4. Pregnant or lactating women;
5. Participation in another clinical trial with investigational medication in the last 3 months;
6. Patients with prior knowledge of infectious disease;
7. Patients who are taking other multivitamins or any other medications for the symptomatic treatment of disorders of cognitive function, at least two weeks prior to study initiation.
8. Patients with organic dementias such as Alzheimer's, Pick's disease, Creutzfeldt-Jacob Disease, Huntington's, Parkinson's disease, dementia caused by human immunodeficiency virus (HIV), hypothyroidism, vascular dementia (arteriosclerotic dementia), dementia senile among others;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01637168
Study Brief:
Protocol Section:
NCT01637168