NCT06604520招募中2 期
Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET)
研究概览
简要总结
The goal of this clinical trial is to learn if vortioxetine improves mood symptoms and cognition in patients with early-stage behavioral variant Frontotemporal Dementia (bvFTD). The main questions this study aims to answer are:
- Do individuals with mood symptoms and bvFTD have brain changes and cognitive profiles that differ compared to individuals without bvFTD?
- Do mood symptoms and cognition improve following treatment with vortioxetine?
Researchers will also determine whether there are changes in the brain associated with vortioxetine treatment.
Participants will:
- Undergo a screening visit that involves clinical assessments and laboratory tests
- Undergo an initial brain magnetic resonance imaging (MRI) and fluorodeoxyglucose (18F) Positron Emission Tomography (FDG PET) scan before starting treatment with vortioxetine
- Undergo memory and problem-solving tests before starting treatment with vortioxetine
- Undergo approximately 12 weeks of treatment with vortioxetine, during which time there will be regular contact and assessments with the study psychiatrist
- Undergo a repeat PET scan and repeat memory and problem-solving tests after 12 weeks of treatment with vortioxetine
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •FTD Patients
- •Inclusion Criteria:
- •Male or Female
- •Age 45 and above
- •Diagnosis of possible or probable bvFTD based on international consensus criteria for behavioral variant FTD (FTDC)
- •The presence of at least one of the following affective symptoms on the 12-item Neuropsychiatric Inventory: depression, anxiety, irritability, or agitation
- •A global Clinical Dementia Rating (CDR®) plus National Alzheimer's Coordinating Center (NACC) Frontotemporal lobar degeneration (FTLD) Behavior and Language Domains global score (CDR® plus NACC FTLD) less than or equal to one
- •Patients must be medically stable
- •Vortioxetine treatment is clinically indicated
- •Competent to provide informed consent
排除标准
- •No history of drug or alcohol dependence within six months prior to study entry
- •Negative toxicology screening for drugs of abuse
- •Subject must not be pregnant or nursing
- •No contraindications to Vortioxetine treatment
- •No contraindications for Magnetic Resonance (MR) scanning (e.g. metal implanted in the body)
- •Healthy Controls
- •Inclusion Criteria:
- •Male or Female
- •Age 45 and above
- •Subjects must be medically stable
- •Free of psychotropic medications
- •Competent to provide informed consent
- •Exclusion Criteria:
- •No current or past history of neurological or psychiatric illness or substance abuse
- •Subject must not be pregnant or nursing
- •Negative toxicology screening for drugs of abuse
- •No contraindications for MR scanning (e.g. metal implanted in the body)
研究组 & 干预措施
Patient Treatment Arm (Vortioxetine)
Experimental
Individuals with bvFTD and mood symptoms receiving the study drug, vortioxetine.
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET)
时间窗: Baseline, 12 weeks
Cerebral glucose uptake measured through 18F FDG positron emission tomography
次要结局
- Change in depressive symptoms as assessed by the Hamilton Depression Rating Scale (HDRS).(Baseline, 12 weeks)
研究者
研究点 (1)
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