Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, 20900, Italy
NCT Number: NCT07479914
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:
* Do memory techniques improve overall cognitive performance, measured by a composite score from a neuropsychological test battery, after 6 months? * Are any cognitive benefits maintained over time (up to 9 months)? * Do biomarkers (such as blood p-tau217 levels, APOE genotype, or brain atrophy on MRI) influence the response to memory training? * Do memory techniques improve subjective cognitive complaints and performance on sensitive memory and cognitive-motor tests?
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.
This study is active but is not currently recruiting participants.
Notify Me50 year and older
All sexes
Interventional
Not applicable
Monza, Lombardy, 20900, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention will consist of:
Other names: Mnemonics, Memory techniques
The control group will receive general information about memory techniques but no structured training or platform access
Time frame: Baseline to 6 months
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.
Time frame: From randomization to 9 months
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.
Time frame: Baseline to 9 months
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.
Time frame: Baseline biomarkers with cognitive change from baseline to 6 and 9 months
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.
Time frame: Baseline to 6 and 9 months
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.
Time frame: Baseline to 6 and 9 months
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.
Time frame: Baseline to 6 and 9 months
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.
Time frame: Baseline to 6 and 9 months
Difference between the active and control groups in longitudinal change in Timed Up and Go test performance, evaluating combined cognitive-motor function.
University of Milano Bicocca
Other
Acronym: MEMO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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