NL-OMON44286已完成2 期
The Effect of a Nutritional Intervention on brain Glucose Metabolism in early Alzheimer*s disease - NL-ENIGMA
Alzheimercentrum0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- diagnosis MCI or mild dementia
- •- with CSF biomarker profile or amyloid PET-scan indicating underlying Alzheimer's disease
- •- age 50*85 years (inclusive)
- •- Mini-Mental State Examination score * 20
- •- informed consent form signed by subject
- •- available reliable study partner (informant) who agrees to monitor administration of study product
排除标准
- •* Diagnosis of significant neurological and / or psychiatric disease other than AD, including vascular dementia according to NINDS-AIREN criteria, cerebral tumour, Huntington*s disease, Parkinson*s disease, normal pressure hydrocephalus (NPH), seizures, delirium, schizophrenia, major depression and other entities relevant for brain function.
- •* Diagnosis of diabetes or use of anti-diabetic medication. Non-fastening blood glucose concentration * 10.0 mmol/l at screening is an exclusion criterion, unless blood glucose concentration is < 7.0 mmol/l when measurement is repeated when patient is in fasting state.
- •* Diagnosis of stroke, intracranial hemorrhage, mass lesion, NPH or white matter hyperintensities according to Fazekas scale 3 on MRI. MRI must not be older than one year.
- •* Use within three months prior to baseline, or expected need during the study, of donepezil, rivastigmine, galantamine and / or memantine
- •* Contraindications to PET or MRI (e.g., claustrophobia, pacemaker, metallic implants, current use of anticoagulants)
- •* Haemoglobin (Hb) level in blood < 7.5 mmol/l (women) or < 8.5 mmol/l (men) at screening
- •* Alcohol or drug abuse
- •* Use within three months prior to baseline of Souvenaid
- •* Use within two months prior to baseline of:
- •- omega-3 fatty acid containing supplements
- •- oily fish (when consumed more than twice a week)
- •* Use within one month prior to baseline of:
- •- atropine, scopolamine, tolterodine, hyoxcyamine, biperiden, benztropine, trihexyphenidyl,
- •- antipsychotics
- •- vitamins B, C and / or E > 200% RDI
- •- high energy and/or protein nutritional supplements / medical foods
- •- benzodiazepines
- •- other investigational products
- •* Change in dose within one month prior to baseline of:
- •- lipid lowering medication
- •- antidepressants
- •- antihypertensive medication
- •* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
- •* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- •* Participation in the LipiDiDiet study within three months prior to baseline
研究者
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