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| Name | Class |
|---|---|
| Villa Beretta Rehabilitation Center | OTHER |
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The goal of this pilot interventional clinical trial (non-drug study) is to learn whether memory techniques (mnemonics) can improve cognitive performance in adults over 50 years old with subjective cognitive decline who are followed at the Brain Health Service of Monza. The study will also evaluate the feasibility of this intervention and explore which biological or clinical factors may influence its effects.
The main questions it aims to answer are:
Researchers will compare a memory training group to a control group receiving information only to see whether structured mnemonic training leads to greater improvement in cognitive outcomes.
Participants will be randomly assigned to either the memory training group or the control group. Both groups will undergo complete cognitive assessments at baseline, 6 months, and 9 months.
If assigned to the training group, participants will attend two in-person group sessions to learn basic and advanced memory techniques, participate in two additional online group meetings, access online video materials, and practice memory exercises on a dedicated online platform for about 20 minutes per day.
If assigned to the control group, participants will receive general information about memory techniques but no structured training or platform access.
A total of 80 participants (40 per group) will be enrolled. This pilot study will help estimate the size of the effect and determine whether a larger future study is feasible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Art of memory | Experimental | The art of memory group will attend two in-person group sessions to learn basic and advanced memory techniques, participate in two additional online group meetings, access online video materials and practice memory exercises on a dedicated online platform for about 20 minutes per day |
|
| Control | Other | The control group will receive general information about memory techniques but no structured training or platform access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Art of memory classes | Other | The intervention will consist of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to 6 months in composite neuropsychological test battery (NTB) z-score (range: - infinity, infinity; higher scores mean better outcomes) | Difference between the active mnemonic training group and the control group in the longitudinal change of the composite z-score derived from a standardized neuropsychological test battery (NTB). The composite score reflects global cognitive performance. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Drop-out rate | Difference in study drop-out rates between the active mnemonic training group and the control group, used as a measure of feasibility and acceptability of the intervention. | From randomization to 9 months |
| Change from baseline to 9 months in composite NTB z-score (range: - infinity, infinity; higher scores mean better outcomes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucio Tremolizzo, MD, PhD | Università degli Studi di Milano-Bicocca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS San Gerardo dei Tintori | Monza | Lombardy | 20900 | Italy |
All anonimized raw data
After completion of the study
Data will be shared upon reasonable request to the Principal Investigator
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
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| General information on art of memory | Other | The control group will receive general information about memory techniques but no structured training or platform access |
|
Difference between the active and control groups in the longitudinal change of the composite z-score derived from the neuropsychological test battery (NTB), evaluating the persistence of cognitive effects. |
| Baseline to 9 months |
| Influence of biological markers on cognitive change | Association between baseline plasma p-tau217 levels, APOE genotype, and MRI-based brain atrophy measures with longitudinal change in composite NTB z-score, to explore predictors of response to mnemonic training. | Baseline biomarkers with cognitive change from baseline to 6 and 9 months |
| Change in Subjective Cognitive Decline Questionnaire (SCD-Q) scores (range: 0-24, higher scores mean worse outcomes) | Difference between the active and control groups in longitudinal change in total and subscale scores of the Subjective Cognitive Decline Questionnaire (SCD-Q), assessing subjective cognitive complaints. | Baseline to 6 and 9 months |
| Change in face-name association test z-score (range: - infinity, infinity; higher scores mean better outcomes) | Difference between the active and control groups in longitudinal change in the z-score of the face-name association test, which is sensitive to early cognitive changes in subjective cognitive decline. | Baseline to 6 and 9 months |
| Change in 1-week memory battery z-score (range: - infinity, infinity; higher scores mean better outcomes) | Difference between the active and control groups in longitudinal change in the z-score of the 1-week delayed memory test, which is sensitive to early cognitive changes in subjective cognitive decline. | Baseline to 6 and 9 months |
| Change in cognitive-motor performance (Timed Up and Go test) | Difference between the active and control groups in longitudinal change in Timed Up and Go test performance, evaluating combined cognitive-motor function. | Baseline to 6 and 9 months |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |