NCT04658654Unknown2 期
A Proof of Concept Phase II Study With the PDE4 Inhibitor Roflumilast in Patients With (Amnestic) Mild Cognitive Impairment (MCI) or Mild Dementia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Verbal Learning Test (VLT) (15 words)
研究概览
简要总结
The aim of the current project is to validate whether chronic intake (24 weeks) roflumilast (PDE4 inhibitor) can improve cognition in patients with (amnestic) mild cognitive impairment (MCI) and in patients with mild dementia. The project will demonstrate whether episodic memory, but also attention, information processing or executive function improves with chronic administration of roflumilast in (a)MCI and mild dementia patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 to 90 years of age
- •Willingness (including the informal caregiver) to sign an informed consent
- •Body mass index (BMI) between 18.5 and 35
- •MMSE of 20 or higher
- •Clinical (amnestic)MCI or mild dementia diagnosis
- •Memory performance on the delayed recall in the clinically relevant 15 words VLT of 1 or more SD below the average
- •Clinical dementia rating (CDR) scale total score of 0.5 or 1
- •Fazekas of 2 or lower
排除标准
- •Normal Pressure Hydrocephalus (NPH)
- •Fazekas of 3 or higher
- •Morbus Huntington
- •Parkinson's disease
- •Hepatitis C & B
- •Recent Transient Ischemic Attack (TIA) (< 2 years)
- •Cerebrovascular Accident (CVA) (< 2 years)
- •TIA/CVA followed by cognitive decline (within 3 months)
- •Chronic Obstructive Pulmonary Disease (COPD) gold criteria 3 or 4 and severe asthma
- •History of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (lifetime)
- •Current radiotherapy
- •Current affective disorder (i.e. anxiety or major depression)
- •Cognitive problems due to alcohol abuse, brain tumor, epilepsy, encephalitis or lack of capacity to consent to participation.
- •Current treatment with (or illicit use of) cannabis, opiates, benzodiazepines, MDMA and cocaine
- •Patients with moderate or major liver impairments will be excluded (e.g. Child-Pugh B and C).
- •Use of medication showing strong inhibition of either CYP3A4 or CYP1A2
- •Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Patients participating in other drug studies
- •If patient does not have the possibility to be accompanied by the same informal caregiver during all test days
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo oral capsule, once daily for 24 weeks
干预措施: Placebo oral tablet (Drug)
Roflumilast 50ug
Experimental
Roflumilast (50 microgram) oral capsule, once daily for 24 weeks
干预措施: Roflumilast (Drug)
Roflumilast 100ug
Experimental
Roflumilast (100 microgram) oral capsule, once daily for 24 weeks
干预措施: Roflumilast (Drug)
结局指标
主要结局
Verbal Learning Test (VLT) (15 words)
时间窗: Change from baseline to 24 weeks of chronic intake
次要结局
- Mini Mental State Examination (MMSE)(Change from baseline to 24 weeks of chronic intake)
- Pattern Separation Task(Change from baseline to 24 weeks of chronic intake)
- Trail-Making Test (TMT)(Change from baseline to 24 weeks of chronic intake)
- Letter Digit Substitution Test (LDST)(Change from baseline to 24 weeks of chronic intake)
- Alzheimer's disease Assessment Scale- Cognitive Sub-scale (ADAS-Cog scale)(Change from baseline to 24 weeks of chronic intake)
- Hospital Anxiety and Depression Scale (HADS)(Change from baseline to 24 weeks of chronic intake)
- Alzheimer's disease co-operative study activities of daily living (ADCS-ADL) scale(Change from baseline to 24 weeks of chronic intake)
- Neuropsychiatric Inventory (NPI)(Change from baseline to 24 weeks of chronic intake)
- QoL-AD(Change from baseline to 24 weeks of chronic intake)
- EuroQol(Change from baseline to 24 weeks of chronic intake)
- Boston Naming Task(Change from baseline to 24 weeks of chronic intake)
研究者
研究点 (1)
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