Art of Memory for Cognitive Enhancement in the Monza Brain Health Service
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline to 6 months in composite neuropsychological test battery (NTB) z-score (range: - infinity, infinity; higher scores mean better outcomes)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Art of memory
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
干预措施: Art of memory classes (Other)
Control
The control group will receive general information about memory techniques but no structured training or platform access
干预措施: General information on art of memory (Other)
结局指标
主要结局
Change from baseline to 6 months in composite neuropsychological test battery (NTB) z-score (range: - infinity, infinity; higher scores mean better outcomes)
时间窗: 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.
次要结局
- Drop-out rate(From randomization to 9 months)
- Change from baseline to 9 months in composite NTB z-score (range: - infinity, infinity; higher scores mean better outcomes)(Baseline to 9 months)
- Influence of biological markers on cognitive change(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)(Baseline to 6 and 9 months)
- Change in face-name association test z-score (range: - infinity, infinity; higher scores mean better outcomes)(Baseline to 6 and 9 months)
- Change in 1-week memory battery z-score (range: - infinity, infinity; higher scores mean better outcomes)(Baseline to 6 and 9 months)
- Change in cognitive-motor performance (Timed Up and Go test)(Baseline to 6 and 9 months)