Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia

Age-Related Memory Disorders Clinical Trial

Official title:

Cognitive Training in Elders Without Dementia Using UMAM Method. Genetic, Brain Volume and Cognitive Reserve Predictors: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04245579
• Other study ID #: 15/382-E_BS
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: May 2015

Study information

• Verified date: January 2020
• Source: Madrid Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Memory Disorders
• Dementia
• Memory Disorders

Intervention

Other:
• Multifactorial Memory Training Program (UMAM method)

Locations

Country	Name	City	State
Spain	Centro de Prevención del Deterioro Cognitivo	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Madrid Salud	Centro de Tecnología Biomédica, Madrid, Hospital San Carlos, Madrid, Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in general cognition	The measure of the post-intervention change in general cognition, assessed with the Mini Mental State Examination Test (MMSE) and the 7 Minutes Test (7M).The score ranges from 0 to 30 points (MMSE) and from 0 to 89 points (7M). In both cases, the higher scores indicate a better outcome.	This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in verbal memory	The measure of the post-intervention change in verbal memory, assessed with the Word List Test of the Wechsler Memory Scale-III. The score ranges from 0 to 48 points. Higher scores indicate a better outcome.	This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in logical memory	The measure of the post-intervention change in immediate and delayed logical memory, assessed with the Logical Memory Test (immediate and delayed units) of the Wechsler Memory Scale-III. The score ranges from 0 to 75 points (immediate units) and from 0 to 50 (delayed units). Higher scores indicate a better outcome.	This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in visual memory	The measure of the post-intervention change in visual memory, assessed with the Rey memory test (form B). The score ranges from 0 to 22 points. Higher scores indicate a better outcome.	This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in daily memory	The measure of the post-intervention change in daily memory, assessed with the Rivermead Behavioral Memory Test. The score ranges from 0 to 24 points. Higher scores indicate a better outcome.	This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in attentional amplitude	The measure of the post-intervention change in attentional amplitude, assessed with the Direct Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 16 points. Higher scores indicate a better outcome.	This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in attentional control	The measure of the post-intervention change in attentional control, assessed with the Inverse Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 14 points. Higher scores indicate a better outcome.	This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in attention and processing speed	The measure of the post-intervention change in attention, assessed with the Trail Making Test, form A. The score ranges from 0 to 200 points. Higher scores indicate a worse outcome.	This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in alternating attention and planning	The measure of the post-intervention change in alternating attention and planning, assessed with the Trail Making Test, form B. The score ranges from 0 to 400 points. Higher scores indicate a worse outcome.	This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in naming ability (language)	The measure of the post-intervention change in naming ability, assessed with the Boston Naming Test. The score ranges from 0 to 60 points. Higher scores indicate a better outcome.	This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in verbal fluency (language)	The measure of the post-intervention change in phonologic and semantic verbal fluency, assessed with the Phonological Verbal Fluency Test and the Semantic Fluency Test respectively. The score goes from zero onwards (there is no upper limit). Higher scores indicate a better outcome.	This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in subjective memory	The measure of the post-intervention change in Subjective Memory, assessed with the Memory Failures of Everyday Questionnaire.The score ranges from 0 to 56 points. Higher scores indicate a worse outcome.	This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	Change in mood	The measure of the post-intervention change in mood, assessed with the Geriatric Depression Scale. The score ranges from 0 to 15 points. Higher scores indicate a worse outcome.	This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Primary	The Cognitive Reserve as a predictor of change.	The Cognitive Reserve was assessed with Rami Test. The score ranges from 0 to 25 points.	Cognitive Reserve was assessed in the pre-intervention assessment.
Primary	The Genetic Profile as a predictor of change.	The Genetic Profile was obtained by genetic analysis employing a blood test. APOE gene has been coded as 1 (meaning no e4 allele), or 0 (for at least one e4 allele).	The Genetic Profile was assessed in the pre-intervention assessment.
Primary	The Brain Volume as a predictor of change.	The Brain Volume (total gray volume, left hippocampus, right hippocampus and total intracranial volume) was assessed by magnetic resonance imaging. Unit of measure: mm3.	The Brain Volume was assessed in the pre-intervention assessment.