NCT07741071招募中2 期
N-AD: A Randomized, Double Blind, Parallel Group, Placebo Controlled, Phase 2 Trial of Orally Administered Nicotinamide Riboside Over Two Years as a Potential Disease Modifying Treatment for Alzheimer's Disease
Haukeland University Hospital4 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2026年8月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 4
- 主要终点
- Disease severity assessed by the Clinical Dementia Rating scale (CDR) sum of boxes.
研究概览
简要总结
The goal of this clinical trial is to learn if orally administered nicotinamide riboside works to slow the progression of early Alzheimer disease in adults. It will also learn about the safety of drug nicotinamide riboside. The main questions it aims to answer are:
- Does drug nicotinamide riboside slow the progression of Alzheimer disease as measured by the Clinical Dementia Rating scale.
- What medical problems do participants have when taking drug nicotinamide riboside? Researchers will compare drug nicotinamide riboside to a placebo (a look-alike substance that contains no drug) to see if nicotinamide riboside works to treat early Alzheimer disease.
Participants will:
- Take drug nicotinamide ribosie or a placebo every day for 24 months
- Visit the clinic once every 26 weeks for checkups and tests
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)
盲法说明
Study participants and investigators are blinded.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis Early clinical AD, e.g. Stage 3 MCI or Stage 4 (mild AD dementia), as defined by the FDA,
- •Biomarker evidence consistent with AD neuropathologic change, defined by CSF markers, i.e. Aβ42 < 1030 ng/L and P-tau181/Aβ42 > 0,023 ng/L and/or T-tau/Aβ42 > 0,28 ng/L* or AD amyloid biomarker (as determined either by visual reading of amyloid PET scans using an approved ligand
- •Diagnosed with AD within 2 years from baseline.
- •Capacity to provide written informed consent for study participation defined as Montreal Cognitive Assessment (MoCA) score ≥ 16 or Mini Mental State Evaluation (MMSE) score ≥
- •MMSE or MoCA must have been performed within 6 months prior to baseline. If there is any doubt regarding the participants capacity to give informed consent, this will be determined by an evaluation by a consultant clinician who is not associated with the N-AD study.
- •Global CDR(33) 0.5-1 (inclusive) at enrollment.
- •Age 50 to 85 years (inclusive) at the time of enrollment.
- •A study partner with sufficient contact to be able to provide data on ADLs and assist the participant in study drug administration. -
- •Cholinesterase inhibitors and memantine can be used if stable for 8 weeks prior to baseline visit.
排除标准
- •Diagnosis of dementia other than probable AD.
- •Abundant vascular pathology, i.e. Fazekas >
- •or >3 lacunar infarcts, stroke involving a major vascular territory, severe small vessel, or white matter disease
- •More than 1 core feature of dementia with Lewy bodies, i.e; recurrent visual hallucination, cognitive fluctuations, REM sleep behaviour disorder, one or more spontaneous cardinal features of parkinsonism (tremor, rigidity and bradykinesia).
- •Comorbidity that precludes study participation or data interpretation.
- •Any psychiatric disorder that would interfere with compliance in the study.
- •Use of high dose vitamin B3 supplementation within 30 days of baseline.
- •Any active neoplastic malignancy (other than non-metastatic dermatological conditions) within two years of the screening visit or current clinically significant haematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disease. Active neoplastic malignancy is defined as having a known malignant focus and/or receiving anti-cancer treatment. For the non-cancer conditions, if the condition has been stable for at least the one year before the screening visit and/or is judged by the site investigator not to interfere with the subject's participation in the study, the subject may be included.
- •Inability to undergo MRI or to comply with study procedures.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo capsules, no active ingredients.
干预措施: Palacebo (Other)
Nicotinamide Riboside (NR)
Experimental
Nicotinamide riboside, 2000 mg for the duration of the trial (104 weeks). Dosage form is capsules.
干预措施: Nicotinamide Riboside (NR) (Dietary Supplement)
结局指标
主要结局
Disease severity assessed by the Clinical Dementia Rating scale (CDR) sum of boxes.
时间窗: From baseline to the end of treatment at 104 weeks.
CDR is a scale assessing clinical impairment in AD. CDR integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following semi-structured caregiver interview and systematic participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The "Sum of boxes" scoring methodology (CDR-SB) sums the score for each of the 6 domains and provides a value ranging from 0 to 18 with higher scores indicating greater impairment. Positive change from baseline indicates greater impairment.
次要结局
- Change from baseline in the MoCA score at Week 104.(From baseline to the end of treatment at 104 weeks.)
- Change from baseline in Amsterdam ADL scale short version (A-IADL-Q-SV) at Week 104.(From baseline to the end of treatment at 104 weeks)
- Change from baseline in delayed recall performance on the CERAD 10-Word List at Week 104(From baseline to the end of treatment at 104 weeks.)
- Change from baseline in executive functioning as measured by Trail-Making Test Part B completion time at Week 104(From baseline to the end of treatment at 104 weeks.)
- Change from baseline in verbal fluency as measured by the COWAT (total correct words for F, A, S) at Week 104.(From baseline to the end of treatment at 104 weeks.)
- Change from baseline in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at Week 104.(From baseline to the end of treatment at 104 weeks.)
研究者
研究点 (4)
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