Multi-Center, Double-Blind, Placebo-Controlled, Monotherapy Study of Neptune Krill Oil (NKO™) in Early Stage Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 14
- 主要终点
- The primary outcome measure will be the change in Neurological Test Battery between baseline and 24 weeks of treatment.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of NKO™ softgels in reducing decline of global cognitive function as measured by the Neuropsychological Test Battery (NTB), in patients diagnosed with early stage Alzheimer's disease when compared to fish oil and a placebo after 24 weeks of treatment.
详细描述
Alzheimer's disease (AD) is an irreversible, progressive neurodegenerative disorder, characterized by gradual cognitive deterioration, changes in behavior and personality. These symptoms are related to neurochemical changes, neural death, and the breakdown of the inter-neural connections. Loss of short-term memory is often the first sign, followed by cognitive deficits involving multiple functions. Early stages of AD and mild cognitive impairment are characterized as milder forms of memory loss or cognitive impairment that could precede the onset of dementia and AD. Prevention of further cognitive decline inpatients with these possible precursor conditions is of paramount importance given that reversibility of AD is not possible.
It is estimated there are currently about 5.1 million people with Alzheimer's disease (AD) in the United States (Alzheimer's Association, 2007) and this number is expected to reach 13.2 millions by 2050 (Hebert et al., 2003). Alzheimer's is ranked as the 7th leading cause of death in the US for people of all ages and the 5th for people aged 65 or older (National Center for Health Statistics, 2004). In Canada it is 280,000 people over 65 that are estimated to have AD, and over 750,000 are expected to have the disease by 2031 (Alzheimer Society of Canada, 2006). It is estimated to 10% of all North Americans over the age of 70 years have early stage AD or mild cognitive impairment.
Older age, low educational level and APOE ε4 allele are risk factors for AD (Lindsay et al., 2002). Moreover, patients having the APOE ε4 allele show an earlier and faster cognitive decline while having the ε2 allele is related to a slower decline. Homozygotous ε4 patients show an even earlier and faster decline than heterozygotes (Martins et al., 2005).
While symptomatic treatments have been the focus of therapeutic investigations for AD, recent research efforts target the toxic effect of amyloid beta (Aβ) peptides in order to modify the underlying pathophysiology of the disease.
The presently approved treatments give only small clinical improvement and do not prevent the progression of the disease, from mild cognitive impairment to dementia and death (Birks et al., 2000; AD2000 Collaborative Group, 2004; Birks, 2006; Birks & Harvey, 2006; Loy & Schneider, 2006).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 50 years or older.
- •Patients with a clinical diagnosis of early stage Alzheimer's disease (NINCDS-ADRDA criteria) and with a Standardized Mini-Mental State Examination (MMSE) score of 20 - 26 inclusively and have demonstrated decline in their cognitive functions during the last six months as determined by the treating physicians.
- •Patient has a score < 9 on the Hamilton Rating Scale for Depression (Ham-D) (Vida et al., 1994; Naarding et al., 2002).
- •If on anti-depressant treatment and/or treatment for any other psychiatric condition the dose must have been stable for six months prior to randomization and should continue to be on the same stable dose for the entire treatment duration.
- •Patient is not taking fish oil or Omega 3/6 supplement 2 weeks before screening visit.
- •Patient is living at home or in a home for elderly persons.
- •Patient has a responsible caregiver who is able to provide information about the patient's functional status.
- •If on a cholinesterase inhibitor treatment the dose must have been stable for at least six months prior to randomization and should continue to be on the same stable dose for the entire treatment duration.
- •If on any concomitant medication treatment the dose must have been stable for at least four months prior to randomization and should continue to be on the same stable dose for the entire treatment duration.
- •Written informed consent is obtained from the patient or the legally accepted representative.
排除标准
- •Women who are pregnant or with childbearing potential and not willing to take adequate birth control measures.
- •Severe or unstable diseases of any type, other than cognitive impairment, that may interfere with outcome evaluations. These include medical conditions expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk.
- •Intake of fish oil or Omega 3/6 supplement other than the study drug
- •Patients are taking more than 400 mg vitamin E.
- •The patient is not able to reliably take the study medication for the duration of the study (Patient compliance is < 60% after the 2-week run-in period).
- •Patients with severe medical condition(s) that in the view of the treating physician prohibits participation in the study.
- •Patients using any other investigational agent, or participating in another study within the last 30 days prior to the baseline visit.
- •Patient with known allergy to fish, seafood or soy/soy-derived products.
- •Patient diagnosed with coagulopathy or on anticoagulant therapy
- •Patient subject to symptomatic hypoglycemia.
- •Patient requires to be initiated on an anti-depressant medication and/or treatment for any other psychiatric condition prior to randomization.
- •Patient requires to be initiated on a cholinesterase inhibitor treatment prior to randomization.
结局指标
主要结局
The primary outcome measure will be the change in Neurological Test Battery between baseline and 24 weeks of treatment.
时间窗: Between baseline and 24 weeks of treatment
次要结局
- Secondary outcome measures will include the change in DAD at 24 weeks of treatment, the change in NTB, GDS, DAD, and MMSE at 12 weeks.Safety and tolerability will be assessed by the incidence of treatment emergent adverse events.(24 week period)