Duke/UNC Alzheimer's Disease Center Clinical Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of participants enrolled who are aged 25 to 44 with normal cognition
研究概览
简要总结
The purpose of the study is to establish a clinical cohort for the Duke/UNC Alzheimer's Disease Research Center (ADRC). The cohort will be composed of subjects ages 25 to 44 at enrollment with normal cognition and subjects ages 45 to 80 at enrollment with normal cognition, mild cognitive impairment, or a dementia diagnosis. Initial data including demographics, medical and family history, physical exam, and neuropsychological testing will be obtained. Participants will be asked to contribute a blood sample, a urine sample, a cerebrospinal fluid sample, and undergo a MRI scan. The cohort ages 45 to 80 will be seen yearly until death to evaluate medical status, undergo neuropsychological testing and possibly collect additional samples or undergo additional imaging. All data will be de-identified and stored by the ADRC.
The purpose of this study is to examine normal cognition, mild cognitive impairment and Alzheimer's disease and related dementias (ADRD) as people get older. The investigators also hope to be able to assess risk factor information of the role of genes and environmental exposures (for example health conditions, diet, and medications) in Alzheimer's disease and related disorders (ADRD) and other conditions of aging.
The biological samples collected in the study will create a repository. A repository is a collection of blood and tissue samples from people with certain diseases and conditions. For the purpose of this research, the investigators hope to help researchers learn more about Alzheimer's disease and related disorders and other conditions of aging.
详细描述
The purpose of the study is to build a clinical cohort of adult research subjects with normal cognition, mild cognitive impairment (MCI), and dementia due to Alzheimer's disease and other related dementias (ADRD), enrolling 100 subjects per year. The primary objective of this cohort will be to advance research on neurodegenerative brain disorders and the role of age, sex and genetics (especially APOE genotype) on their manifestation.
The primary objective is to create a clinical cohort for the Duke/UNC Alzheimer's Disease Research Center (ADRC). The ages of the cohort will be 25 to 44 and 45 to 80 at the time of enrollment. Subjects aged 45 to 80 must have a project partner as part of the study. The cohort will undergo baseline data collection according to the Uniform Data Set, version 3 set forth by the National Alzheimer's Coordinating Center including medical and family history, physical exam, neuropsychological testing, blood and urine sample, cerebrospinal fluid sample, and brain MRI. A subject's project partner can be substituted for another one, and if so, the new potential project partner will be consented into the study. Subjects in the ages 45 to 80 group will be re-evaluated every year with a medical history update, physical exam, and neuropsychological testing.
Additional blood, fluid or imaging may be requested at later dates. As part of their enrollment in the cohort the subjects will be presented yearly to a consensus committee to confirm diagnosis. A subset of the cohort ages 45 to 80, unable or unwilling to have the Lumbar Puncture, may alternately be offered to supplement a PET Scan to confirm diagnosis if/when AD symptoms are present.
The Duke/UNC ADRC obtained funding from the National Institute of Aging (NIA) in September 2021 and is an NIA designated ADRC program.
Subjects with normal cognition, mild cognitive impairment and dementia diagnosis will be recruited from clinical visits at the Duke Neurology Memory Disorders Clinic at Morreene Road. Subjects will also be enrolled by self-referral and active recruitment through participation in existing studies, registries, educational talks at community organizations and community health fairs. Subjects in the ages 45-80 cohort must have a dedicated project partner of their choice at time of enrollment. The project partner is an individual who knows the participant well, preferably a family member (e.g. spouse, adult child).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each subject must be ≥ 25 to ≤ 80 years of age.
- •Each subject must be able to read at a 6th grade level, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude intellectual disability.
- •Each subject (or legal representative) must sign the informed consent form after the scope and nature of the investigation have been explained to them, and before screening assessments. Some consent may be obtained via phone script and REDCap eConsent.
- •Each participant must be willing to have an MRI and a lumbar puncture, or alternately (to the lumbar puncture) a series of PET scans.
- •Each participant ages 45 to 80 must have a study partner who agrees to participate in the study and who is able to read at a 6th grade level, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude intellectual disability.
排除标准
- •Evidence of a clinically relevant or unstable neurological disorder including history of multiple head injuries, stroke or other CNS conditions (MS, Parkinson's disease, etc.)
- •Evidence of a clinically relevant or unstable psychiatric disorder.
- •History of alcoholism or drug dependency/abuse within the last 2 years before enrollment.
- •GAD-7 score >9 and/or PHQ-8 score >9
- •An ongoing uncontrolled, clinically significant medical condition such that, in the judgment of the investigator, a subject's participation in the trial would pose a significant medical risk to the subject.
- •Contraindication or intolerance to 3T MRI investigations, including implanted devices
- •History of malignancy of any organ system, treated or untreated, within the past 60 months, regardless of whether there is evidence of local recurrence or metastases. However localized nonmalignant tumors not requiring systemic chemo- or radiotherapy, localized basal or squamous cell carcinoma of the skin, or in-situ cervical cancer are permitted.
研究组 & 干预措施
Participants aged 25-44
Subjects ages 25 to 44 at enrollment with normal cognition will undergo baseline visits including:
- Demographics
- Family history, medical history, current medications
- General physical and neurological exam, sensory and motor testing
- Vital signs
- Blood sample collected for PT/INR, blood count, genetic testing, and storage for future unspecified research on cognition and disorders associated with altered cognition
- Urine sample
- Neuropsychological testing
- Retinal imaging
- Testing of memory, thought processes, and recognition
- MRI
- Lumbar puncture
Participants aged 45-80
Subjects ages 45 to 80 at enrollment with normal cognition, mild cognitive impairment, or dementia will undergo baseline visits including:
- Demographics and project partner demographics
- Family history, medical history, current medications
- General physical and neurological exam, sensory and motor testing
- Vital signs
- Blood sample collected for PT/INR, blood count, genetic testing, and storage for future unspecified research on cognition and disorders associated with altered cognition
- Urine sample
- Neuropsychological testing
- Retinal imaging
- Testing of memory, thought processes, and recognition
- MRI
- Lumbar puncture
Participants will be asked to participate in yearly evaluations until the time of death. Participants can withdraw at any time.
结局指标
主要结局
Number of participants enrolled who are aged 25 to 44 with normal cognition
时间窗: Until the end of the study, approximately 5 years
The primary objective of this cohort will be to advance research on neurodegenerative brain disorders and the role of age, sex and genetics (especially APOE genotype) on their manifestation.
Number of participants enrolled who are aged 45 to 80 with normal cognition
时间窗: Until the end of the study, approximately 5 years
The primary objective of this cohort will be to advance research on neurodegenerative brain disorders and the role of age, sex and genetics (especially APOE genotype) on their manifestation.
Number of participants enrolled who are aged 45 to 80 with mild cognitive impairment (MCI)
时间窗: Until the end of the study, approximately 5 years
The primary objective of this cohort will be to advance research on neurodegenerative brain disorders and the role of age, sex and genetics (especially APOE genotype) on their manifestation.
Number of participants enrolled who are aged 45 to 80 with dementia
时间窗: Until the end of the study, approximately 5 years
The primary objective of this cohort will be to advance research on neurodegenerative brain disorders and the role of age, sex and genetics (especially APOE genotype) on their manifestation.
次要结局
未报告次要终点