Attentional performance, cognition, and mental wellbeing of middle-aged and older healthy adults with subjective cognitive function complaints Signs and Symptoms
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements 2. Aged =50 years old or =75 years old, male or female (including the boundary value) 3. Male body weight =50kg, female body weight =45kg, and 18.0 =BMI =29.9 kg/m2 4. No clinically significant cognitive impairment (MoCA > 25) 5. Self-reported subjective cognitive complaints 6. Literacy to complete tests
Exclusion criteria
Exclusion criteria: 1. History of drug abuse or alcohol abuse (drank more than 14 units/week of alcohol: 1 unit =285 ml beer, 25 ml spirits or 100 ml wine) 2. Gastric sleeve patients 3. History of drug abuse within 5 years prior to screening, or urine drug screening test was positive 4. Other clinically major diseases, such as decompensated, in the investigator's judgment (such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, metabolic endocrine system, blood system, skin diseases, immune diseases, tumors, etc) 5. Participation in another clinical trial within 3 months prior to enrollment 6. Pre-existing and active major neurological disease 7. Injury of writing hand influencing cognitive or other outcome measures, in the investigator’s judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The three following primary outcome variables will be measured using the Test of Attentional Performance (TAP) at 0, 30, 90 and 180 days: 1. Alertness (phasic alertness) 2. Working Memory (difficulty level 3) 3. Divided Attention | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome variables will be measured at 0, 30, 90 and 180 days: 1. IQ measured using the Wechsler Adult Intelligence Scale (WAIS-IV) - Digit Span Forward, Backward (DSF, DSB) 2. Stress measured using the Perceived Stress Scale (PSS) 3. Mood measured using the Brief Mood Introspection Scale (BMIS) 4. Sleep quality measured using the Sleep Quality Scale (SQS) 5. Health-related quality of life measured using the EuroQol EQ-5D-5L questionnaire | — |
Countries
Romania