A Single Center Feasibility Study of Intranasal Insulin in Frontotemporal Dementia NIFT-D
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Feasibility Measured by EXAMINER Battery
研究概览
简要总结
This project will study intranasal (IN) insulin in Frontotemporal dementia (FTD) in 12 patients. Study Investigators aim to evaluate the feasibility of the EXAMINER cognitive battery as a cognitive outcome measure in FTD, the ability of the HealthPartners Center for Memory and Aging's ability to sufficiently recruit subjects with FTD, and the safety of IN regular insulin administered 20 IU twice per day in two specific variants of FTD (behavioral variant frontotemporal dementia (bv-FTD), semantic dementia (SD)) over a 4 week period.
详细描述
Frontotemporal dementia (FTD) with its multiple pathological manifestations, is a disease that results in progressive deterioration of social comportment, executive function, and language. Despite the debilitating nature of FTD and the relatively high prevalence in the younger patient population, available pharmacological interventions are limited to symptomatic treatments. There are no therapeutic agents that have been developed that specifically treat the progressive cognitive symptoms of FTD. This project will study IN insulin in FTD in 12 patients. Investigators aim to evaluate the feasibility of the EXAMINER cognitive battery as a cognitive outcome measure in FTD, the ability of the HealthPartners Center for Memory and Aging's Center's ability to sufficiently recruit subjects with FTD, and the safety of IN regular insulin administered 20 IU twice per day in two specific variants of FTD (behavioral variant frontotemporal dementia (bv-FTD), semantic dementia (SD)) over a 4 week period. Frontotemporal dementia (FTD) with its multiple pathological manifestations, is a disease that results in progressive deterioration of social comportment, executive function, and language. Despite the debilitating nature of FTD and the relatively high prevalence in the younger patient population, available pharmacological interventions are limited to symptomatic treatments. There are no therapeutic agents that have been developed that specifically treat the progressive cognitive symptoms of FTD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 41 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subject meeting international consensus criteria for probable behavioral variant frontotemporal dementia or criteria for semantic dementia (Gorno-Tempini et al., 2011; Rascovsky et al., 2011)
- •Subject has a Mini-Mental State Exam (MMSE) score ≥
- •Subject is > 40 and <90 years of age.
- •Female subjects are post-menopausal or have a negative pregnancy test
- •The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing of cognitive function, memory and physiology.
- •Subject has a dedicated family member/caregiver, who will be able to attend all visits and report on subject's status.
- •Subject and family member/caregiver have both provided fully informed written consent prior to participation. In the event that subject is legally unable to provide informed written consent due to deterioration in cognitive abilities, fully informed written consent must be provided by a legally authorized representative.
- •Subject must have undergone a brain computed tomography (CT) scan or magnetic resonance imaging (MRI) scan as part of receiving frontotemporal dementia (FTD) diagnosis
排除标准
- •Subject has medical history and/or clinically determined evidence of other central nervous system (CNS) disorders including, but not limited to brain tumor, active subdural hematoma, seizure disorder, multiple sclerosis, Alzheimer's disease, vascular dementia, corticobasal syndrome, progressive supranuclear palsy, Parkinson's disease, multiple system atrophy, Lewy body dementia, normal pressure hydrocephalus, Huntington's disease, or Jakob-Creutzfeldt disease presenting as dementia.
- •Subject has medical history and/or clinically determined disorders: current B12 deficiency, chronic sinusitis, untreated thyroid disease, or significant head trauma.
- •Subject has history of any of the following: moderate to severe pulmonary disease, poorly controlled congestive heart failure, significant cardiovascular and/or cerebrovascular events within previous 6 months, condition known to affect absorption, distribution, metabolism, or excretion of drugs such as any hepatic, renal or gastrointestinal disease or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator.
- •Subject has had previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies.
- •Subject has a history of any psychiatric illness that would pose a safety risk to the subject as determined by investigator.
- •Subject is currently taking any medications (anticholinergics, antihistamines, benzodiazepines, barbiturates, or insulin) that are clinically contraindicated as determined by investigator.
- •Subject has undergone a recent change (<1 month) in their selective serotonin reuptake inhibitors (SSRI) or anti-depressant medication.
- •Subject has current or recent drug or alcohol abuse or dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders 5, Text Revision (DSM-IV TR).
- •Screening laboratory results that are medically relevant, in which inclusion would pose a safety risk to the subject as determined by investigator.
- •The subject has participated in a clinical trial investigation within 1 month of this study.
- •The subject has an insulin allergy.
研究组 & 干预措施
Insulin (Novolin-R)
Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID
干预措施: Novolin-R insulin (Drug)
结局指标
主要结局
Feasibility Measured by EXAMINER Battery
时间窗: Baseline and Post Treatment
Number of patients completing the entire EXAMINER battery. Range: 0-3. More participants completing EXAMINER indicates higher feasibility.
Safety Measured by Total Serious Adverse Events (SAEs) and Adverse Events (AEs)
时间窗: 2 months
Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment.
Feasibility Measured by Recruitment
时间窗: Baseline
Number of patients enrolled in this study. Range: 0-12. More participants enrolling indicates higher feasibility.
次要结局
- Feasibility Measured by Screen Fails(2 years)
- Safety Measured by Unique Subjects With Serious Adverse Events (SAEs) and Adverse Events (AEs)(4 weeks)
- Feasibility Measured by Completion of Study(2 months)