ASL 2 Turin, Piedmont, Italy.
Clin Interv Aging. 2013;8:131-7. doi: 10.2147/CIA.S38420. Epub 2013 Feb 5.
The studio di intervento nel decadimento vascolare lieve (IDEALE study) was an open multicenter Italian study, the aim of which was to assess the effectiveness and safety of oral citicoline in elderly people with mild vascular cognitive impairment.
The study was performed in 349 patients. The active or citicoline group was composed of 265 patients and included 122 men and 143 women of mean age 79.9 ± 7.8 years selected from six Italian regions. Inclusion criteria were age ≥ 65 years, Mini-Mental State Examination (MMSE) score ≥ 21, subjective memory complaints but no evidence of deficits on MMSE, and evidence of vascular lesions on neuroradiology. Those with probable Alzheimer's disease were excluded. The control group consisted of 84 patients, including 36 men and 48 women of mean age 78.9 ± 7.01 (range 67-90) years. Patients included in the study underwent brain computed tomography or magnetic resonance imaging, and plasma dosage of vitamin B12, folate, and thyroid hormones. Functional dependence was investigated by scores on the Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scales, mood was assessed by the Geriatric Depression Scale (GDS), and behavioral disorders using the Neuropsychiatric Inventory scale. Comorbidity was assessed using the Cumulative Illness Rating Scale. An assessment was made at baseline (T0), after 3 months (T1), and after 9 months (T2, ie, 6 months after T1). The main outcomes were an improvement in MMSE, ADL, and IADL scores in the study group compared with the control group. Side effects were also investigated. The study group was administered oral citicoline 500 mg twice a day throughout the study.
MMSE scores remained unchanged over time (22.4 ± 4 at T0; 22.7 ± 4 at T1; 22.9 ± 4 at T2), whereas a significant difference was found between the study and control groups, both in T1 and in T2. No differences were found in ADL and IADL scores between the two groups. A slight but not statistically significant difference was found in GDS score between the study and control groups (P = 0.06). No adverse events were recorded.
In this study, citicoline was effective and well tolerated in patients with mild vascular cognitive impairment. Citicoline activates biosynthesis of phospholipids in neuronal membranes, increases brain metabolism as well as norepinephrine and dopamine levels in the central nervous system, and has neuroprotective effects during hypoxia and ischemia. Therefore, citicoline may be recommended for patients with mild vascular cognitive impairment.
轻度血管性认知障碍干预研究（IDEALE 研究）是一项开放性、多中心的意大利研究，旨在评估口服胞磷胆碱在老年轻度血管性认知障碍患者中的有效性和安全性。
该研究纳入了 349 例患者。实验组或胞磷胆碱组包括 265 例患者，其中 122 例为男性，143 例为女性，平均年龄为 79.9±7.8 岁，来自意大利的 6 个地区。纳入标准为年龄≥65 岁、简易精神状态检查（MMSE）评分≥21、有主观记忆障碍但 MMSE 检查无缺陷、且神经影像学检查有血管病变。排除可能患有阿尔茨海默病的患者。对照组包括 84 例患者，其中 36 例为男性，48 例为女性，平均年龄为 78.9±7.01（范围 67-90）岁。入组患者均行脑 CT 或磁共振成像检查，检测血浆维生素 B12、叶酸和甲状腺激素水平。采用日常生活活动量表（ADL）和工具性日常生活活动量表（IADL）评估患者的功能依赖程度，采用老年抑郁量表（GDS）评估情绪，采用神经精神问卷量表评估行为障碍。采用累积疾病评分量表评估共病情况。在基线（T0）、3 个月（T1）和 9 个月（T2，即 T1 后 6 个月）时进行评估。主要结局为实验组与对照组相比，MMSE、ADL 和 IADL 评分的改善。还对不良反应进行了研究。实验组患者在整个研究期间每天口服胞磷胆碱 500mg，分两次服用。
MMSE 评分在整个研究过程中保持不变（T0 时为 22.4±4，T1 时为 22.7±4，T2 时为 22.9±4），但实验组与对照组之间在 T1 和 T2 时均存在显著差异。两组 ADL 和 IADL 评分无差异。实验组与对照组之间 GDS 评分存在轻微但无统计学意义的差异（P=0.06）。未记录到不良事件。
在这项研究中，胞磷胆碱在轻度血管性认知障碍患者中有效且耐受性良好。胞磷胆碱可激活神经元膜中磷脂的生物合成，增加大脑代谢以及中枢神经系统中去甲肾上腺素和多巴胺的水平，并且具有在缺氧和缺血时的神经保护作用。因此，胞磷胆碱可推荐用于轻度血管性认知障碍患者。
