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维克森林阿尔茨海默病临床核心 (ADCC)

2026年10月5日 更新者:Wake Forest University Health Sciences

Efforts to find treatments for AD have yielded only modest benefits, likely because longstanding AD pathological processes induce irreversible neurological compromise. These processes begin years before the onset of clinical symptoms. This possibility has been incorporated into a model describing stages of AD development, articulated by the NIA/Alzheimer's Association preclinical workgroup of which the Co-Director of the Kulynych Alzheimer's Research Center, Dr. Suzanne Craft, was a member. According to this model, the best hope for countermanding the effects of AD lies in intervening at the earliest possible point in the pathological cascade. There are several important ongoing efforts in adults with preclinical AD that directly target amyloid aggregation. Although this strategy addresses an important aspect of the AD pathological cascade, we believe that addressing metabolic dysfunction affecting glucose and insulin regulation offers a complementary approach, in that it may reduce amyloid burden and toxicity, while also directly enhancing synaptic health, brain metabolism, tau regulation and neurovascular function.

The purpose of the ADCC is to identify and characterize early risk factors that predict cognitive decline and dementia in asymptomatic adults and adults with early signs of cognitive impairment. The data obtained from this study, collected at enrollment and follow-up will allow us to examine disease trajectory in individuals with and without prediabetes and other measures of glucoregulatory dysfunction in this process. The enrollees, who will be well-characterized with regard to cognitive and metabolic status through ADCC assessments, will provide an important resource for other local (institution) and national investigations. Data collected from participants enrolled in the ADCC will be stored indefinitely for future investigations.

研究概览

地位

招聘中

条件

详细说明

The data and specimen repository of the ADCC study will provide a unified mechanism for cataloging and storing data that can be efficiently shared across studies. This repository will also allow for important collaborations with other Alzheimer's Disease Centers across the US that are performing similar investigations of adults at increased risk of dementia. Data sharing across multiple institutions and investigators will be critical to optimize speed of acquisition and standardization of outcomes that may ultimately lead to the development of innovative tools for early detection and new treatment strategies. The repository will include cognitive data, human specimen samples (blood, cerebrospinal fluid), medical and family history information, and neuroimaging data. Data collected from participants enrolled in the ADCC will be stored indefinitely for future investigations.

Participants will include adults at least 55 years old, with or without a cognitive deficit, who meet criteria for inclusion into one of the groups described below. Males and females will be equal to distribution in the Triad area population. Additional recruitment efforts targeting underserved communities will be used to increase representation of these adults in the study cohort beyond what is typical in other local and national studies of AD.

Eligible participants will have the option to participate in the core ADCC study and also in a biomarker-intensive substudy that will collect additional measurements of brain function and chemical markers of AD pathology. While all participants enrolled in the core ADCC study will receive brain magnetic resonance imaging (MRI). Those enrolled in the substudy will complete a lumbar puncture (LP) to permit quantification of AD biomarkers in cerebrospinal fluid (CSF). Participants enrolled in the substudy will be referred to as the Biomarker-Intensive Group, or ADCC-BIG.

At study entry, participants will meet inclusion criteria for membership in one of the groups that differ according to cognitive status and metabolic health (described below). Once enrolled, a change in cognitive or metabolic status will not affect eligibility to receive follow-up assessments as part of this study, although frequency of assessment may change (i.e., enrollees who progress to late-stage AD or type 2 diabetes will not be dis-enrolled). Eligible participants who choose to also enroll in ADCC-BIG must agree to complete the LP. If participants have screened or participated in another Kulynych Center study within the last 3 months, some data may be reused to avoid redundant data collection and reduce participant burden. This data may include specimen samples such as blood or CSF, cognitive testing data and MRI imaging data.

研究类型

观察性的

注册 (估计的)

850

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • North Carolina
      • Winston-Salem、North Carolina、美国、27157
        • 招聘中
        • Wake Forest Baptist Health
        • 首席研究员:
          • Jeff Williamson, MD
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adults, 55 years old and older, who have normal memory, mild memory impairment or AD. All subjects will be in reasonably good health with no significant medical illness that may contribute to memory decline other than MCI or probable AD.

描述

Inclusion Criteria:

Group 1: Cognitively Normal (CN)

  1. No subjective complaints of cognitive impairment
  2. No cognitive impairment evident on formal testing interpreted by expert adjudication committee (typically, performance not worse than 1 SD below demographically relevant norms)
  3. Clinical Dementia Rating (CDR) = 0 or 0.5
  4. Normal glycemic control as indicated by American Diabetes Association (ADA) guidelines for normal 2 hour glycemic response to a glucose tolerance test (< 140 mg/dL).
  5. Reliable collateral or study partner available to attend Visit 1 at a minimum

Group 2: Mild Cognitive Impairment (MCI)

  1. Objective evidence of memory and/or executive function deficits on neuropsychological testing (typically 1.5 SD below demographically relevant norms)
  2. CDR = 0 or 0.5
  3. Reliable collateral or study partner

Group 3: Alzheimer's Disease (AD)

  1. Diagnosis of probable mild AD, diagnosed with NIA-AA criteria, or mixed AD and vascular pathology as long as there is not a large vessel territory stroke, adjudicated by expert consensus panel.
  2. Mini-Mental Status Exam (MMSE) score ≥ 10; CDR = ≥0.5
  3. Normal glycemic control or prediabetes
  4. Reliable collateral or study partner available to attend all visits

Exclusion Criteria:

  1. Clinically significant abnormal labs
  2. Significant neurologic disease that might affect cognition, other than AD, such as stroke, Parkinson's disease, multiple sclerosis, or recent severe head injury with loss of consciousness for more than 30 minutes within the last year, or with permanent neurologic sequelae
  3. Clinically significant medical illness or organ failure as determined by study clinicians, including severe, uncontrolled cardiovascular disease, oxygen-treated chronic obstructive pulmonary disease, severe liver disease, Stage 4 chronic kidney disease or impending dialysis, active cancer, or other life-limiting condition with life expectancy less than 3 years
  4. Current substance abuse or heavy alcohol consumption defined as >14 alcoholic drinks per week; or history of alcoholism or substance abuse within previous 10 years
  5. Current poorly controlled depression or other psychiatric illness as determined by clinical judgement of study clinicians or neuropsychologists
  6. Current use of anti-psychotic, benzodiazepines (PRN use <3 times per week is acceptable), anti-coagulants (for participants who will receive a lumbar puncture), strongly anticholinergic or sedative medications
  7. Use of anticonvulsant for seizure disorder. (Use of anticonvulsant to treat other illnesses will be reviewed by the study MD and eligibility will be determined on a case by case basis.)
  8. Current use of insulin
  9. Brain MRI contraindications; including use of pacemakers, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes will be excluded from MRI
  10. For participants completing any brain imaging protocol, inability to lie on the scanner bed for 40 minutes, or claustrophobia
  11. For ADCC-BIG, significant obesity or a lower back condition that is likely to impede successful collection of CSF, as determined by study physician judgment
  12. Other significant medical conditions at the investigators' discretion

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
Cognitively Normal

This group will include 300 healthy volunteers with no apparent memory problems. Participants will complete an assessment at enrollment and once per year for the following 5 years. In addition to memory assessments at baseline and year 4, participants will have a brain MRI, OGTT A reliable study partner will need to attend the visits or be available via telephone to complete study interviews.

Mild Cognitive Impairment

This group will include 400 volunteers who have mild memory problems that are observed during cognitive testing. Participants will complete an assessment at enrollment and once per year for the following 5 years. In addition to memory assessments at baseline and year 4, participants will have a brain MRI, OGTT A reliable study partner will need to attend the visits or be available via telephone to complete study interviews.

Alzheimer's disease

This group will include 150 volunteers with mild stage Alzheimer's disease dementia. Participants will complete an assessment at enrollment and once per year for the following 5 years. In addition to memory assessments at baseline and year 4, participants will have a brain MRI, OGTT A reliable study partner will need to attend visits to complete study interviews.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in performance on cognitive measures.
大体时间:5 years

Cognitive measure such as memory, verbal fluency and executive function will be assessed annually, either by phone or in person depending on group.

5 years

次要结果测量

结果测量
措施说明
大体时间
Change in biomarker levels in cerebrospinal fluid (CSF).
大体时间:5 years

Biomarkers associated with Alzheimer's will be measured in participants who agree to participate in the Biomarker-Intensive Group.

5 years
Change in brain volumes on magnetic resonance imaging (MRI).
大体时间:5 years

MRI measures of brain volumes by region of interest, such as hippocampus, will be assessed during the baseline visit and again 3 years later (approximately week 156).

5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

合作者

调查人员

  • 首席研究员:Jeff Williamson, MD、Wake Forest University Health Sciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年1月1日

初级完成 (估计的)

2030年1月1日

研究完成 (估计的)

2031年1月1日

研究注册日期

首次提交

2014年12月19日

首先提交符合 QC 标准的

2017年5月2日

首次发布 (实际的)

2017年5月4日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月5日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB00025540
  • 40010560 (其他标识符:National Institute on Aging)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

The ADCC is an observational study that will collect and store data at study entry and longitudinally for use in future studies. As part of the ADCC, the investigator will ask permission to store biological samples (blood, cerebrospinal fluid), as well as cognitive and medical data (neuroimaging, cognitive status, metabolic function markers, and family history information) indefinitely for future analyses. The Wake ADCC is part of a National collection of ADCCs funded by the NIA and as such, all centers contribute data to a central repository (National Alzheimer's Coordinating Center (NACC) at University of Washington). Participants will consent to have their de-identified data sent to the NACC.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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