Alzheimer's Disease, Cognitive Enhancement, Subjective Cognitive Decline (SCD)
Conditions
Keywords
Subjective Cognitive Decline, Alzheimer's disease, pTau-217, art of memory, Cognitive enhancement
Brief summary
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.
Interventions
OTHERArt of memory classes
The intervention will consist of: * two in-person and two online group sessions to learn basic and advanced memory techniques, taught by experienced memory athletes (Vanni de Luca, Andrea Muzii and Alessandro de Concini) * dedicated online video materials * self-paced exercises on the memoryleague.com website for about 20 minutes per day
OTHERGeneral information on art of memory
The control group will receive general information about memory techniques but no structured training or platform access
Sponsors
University of Milano Bicocca
Villa Beretta Rehabilitation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Subjective Cognitive Decline (SCD) according to Jessen et al., 2014 criteria * Evaluation at the Brain Health Service (BHS) of Monza * Prior brain MRI performed at Fondazione IRCCS San Gerardo dei Tintori * Prior blood sampling for measurement of biomarkers of cerebral amyloidosis * Age \> 50 years * Adequate digital literacy (ability to access websites and participate in video calls) * Ability and willingness to provide written informed consent before study participation
Exclusion criteria
* Severe visual and/or hearing impairment interfering with participation * Inability to participate in online training activities or attend in-person group sessions * Enrollment in another interventional study with an expected effect on cognition * Refusal or withdrawal of consent to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 6 months in composite neuropsychological test battery (NTB) z-score (range: - infinity, infinity; higher scores mean better outcomes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drop-out rate | 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. |
| Change from baseline to 9 months in composite NTB z-score (range: - infinity, infinity; higher scores mean better outcomes) | 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. |
| Influence of biological markers on cognitive change | 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. |
| Change in Subjective Cognitive Decline Questionnaire (SCD-Q) scores (range: 0-24, higher scores mean worse outcomes) | 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. |
| Change in face-name association test z-score (range: - infinity, infinity; higher scores mean better outcomes) | 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. |
| Change in 1-week memory battery z-score (range: - infinity, infinity; higher scores mean better outcomes) | 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. |
| Change in cognitive-motor performance (Timed Up and Go test) | 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. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORLucio Tremolizzo, MD, PhD
Università degli Studi di Milano-Bicocca
Outcome results
None listed