A randomized clinical trial through combined therapy in patients with mild cognitive impairment

Not Applicable

• Conditions: Mental and Behavioural Disorders; Mild Cognitive Impairment (MCI)

• Registration Number: ISRCTN87597719
• Lead Sponsor: niversidad del Desarrollo

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38395980/ (added 26/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-15
• Last Update Posted: 11 March 2024
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Age equal to or greater than 60 years
2. Presence of Mild Cognitive Impairment, according to the diagnostic criteria established in Petersen et al. (2014)
3. Have six or more years of complete schooling (presence of reading and writing)

Exclusion Criteria

1. The previous diagnosis of other neurodegenerative diseases
2. Attending another cognitive training program
3. History of Epilepsy or current presence of epileptic seizures
4. Presence of psychiatric diseases
5. Presence of a relevant depressive picture (GDS >=2)
6. History of important neurological alterations such as the history of stroke, transient ischemic attack, cranial brain trauma
7. Important alterations of communication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prefrontal theta oscillation activity is measured using electrophysiological changes underlying the working memory process at baseline, 13 and 20 weeks

Secondary Outcome Measures

Name	Time	Method
1. Working Memory Index is measured using WAIS-IV Digit Retention subtest at baseline, 13 and 20 weeks<br>2. Working memory and the capacity for cognitive flexibility are measured using Trail Making Test B (TMT-B) at baseline, 13 and 20 weeks