Clinical trial NCT04245579: Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia
Official title: Cognitive Training in Elders Without Dementia Using UMAM Method. Genetic, Brain Volume and Cognitive Reserve Predictors: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Memory Disorders
Keywords: cognitive training
memory failures
APOE
brain volume
cognitive reserve
Lead sponsor: Madrid Salud
Sponsor class: OTHER
Collaborators: name: Universidad Complutense de Madrid
name: Hospital San Carlos, Madrid
name: Centro de Tecnología Biomédica, Madrid
First posted: 2020-01-29
Enrollment: 199
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is oriented to analyze the effectiveness of a cognitive training method (UMAM) on cognitive functions, subjective memory and mood state in elderly people without dementia. On the other hand, the study aims to examine whether variables such as cognitive reserve (e.g. educational level), APOE genotype and intracranial volume are related to increased benefit after the intervention. The researchers hope to find that greater cognitive reserve, not having the APOE allele ε4, and a greater volume of memory-related brain areas, are associated with better outcomes after the cognitive intervention.


Eligibility criteria: Inclusion Criteria:

* Being over 60 years old.
* Having a global cognitive performance \> 23 in the Mini Mental State Examination Test.
* Having no history of neurological or serious psychiatric disorders (severe psycho-affective disorders and psychosis or other psychiatric disorders like alcoholism).

Exclusion Criteria:

* Chronic use of anxiolytics.
* Chronic use of neuroleptics.
* Chronic use of anticonvulsants.
* Having hearing or vision impairments that would preclude testing.
* Magnetic Resonance Imaging (MRI) contraindications.

Primary outcomes:
measure: Change in general cognition
timeFrame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in verbal memory
timeFrame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in logical memory
timeFrame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in visual memory
timeFrame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in daily memory
timeFrame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in attentional amplitude
timeFrame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in attentional control
timeFrame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in attention and processing speed
timeFrame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in alternating attention and planning
timeFrame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in naming ability (language)
timeFrame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in verbal fluency (language)
timeFrame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in subjective memory
timeFrame: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: Change in mood
timeFrame: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
measure: The Cognitive Reserve as a predictor of change.
timeFrame: Cognitive Reserve was assessed in the pre-intervention assessment.
measure: The Genetic Profile as a predictor of change.
timeFrame: The Genetic Profile was assessed in the pre-intervention assessment.
measure: The Brain Volume as a predictor of change.
timeFrame: The Brain Volume was assessed in the pre-intervention assessment.
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro de Prevención del Deterioro Cognitivo
Study officials:
References: