Sleep and Temperature Disturbance as risk factors for Alzheimer's Disease in Down Syndrome: a Longitudinal Study.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary endpoint derived from radiopharmaceutical administration of the radiopharmaceutical will be the Standardized uptake value ratio (SUVR) of the images generated with 18F-PI- 2620, which will be co-registered with the structural magnetic resonance magnetic resonance imaging (MRI) using SPM12 software. The cerebellum will be used as the reference region.
研究概览
简要总结
Study the relationship between sleep disorders and circadian variations in body temperature as risk factors for the progression of Alzheimer's disease in Down's syndrome.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects with Down syndrome of both sexes between 40 and 60 years.
- •With a degree of intellectual disability that allows completing the CAMCOG cognitive battery.mild or moderate.
- •Diagnosis of Down syndrome confirmed by karyotyping.
- •Patients with good general health.
排除标准
- •Inability to give informed consent.
- •Any significant unstable medical or psychiatric condition or disease.
- •Common contraindications for MRI (claustrophobia, pacemaker, aneurysm clip, etc.). aneurysm clip, etc.).
- •Psychiatric illnesses that may affect cognition, such as bipolar disorder or schizophrenia, or the use of medications or substance abuse.
- •Current use of sedatives/hypnotics, stimulants, antipsychotics, gabapentin, pregabalin, tricyclic antidepressants and trazodone, or other psychoactive medications that may alter slow wave sleep (SWS) or body temperature
- •Gastrointestinal conditions that may present a risk of bowel wall protrusion.
- •Use of new psychoactive drugs in the three months prior to the study.
- •Irregular sleep cycles, extremely long or short total sleep duration and extreme unstable circadian mismatch (3 months or more).
- •Medical conditions including uncontrolled pulmonary or cardiac disease, untreated hypothyroidism, brain tumors, stroke, head trauma and hydrocephalus. It should be noted that thyroid status will be assessed by TSHs and Free T3 and T4 at the time of medical screening.
结局指标
主要结局
The primary endpoint derived from radiopharmaceutical administration of the radiopharmaceutical will be the Standardized uptake value ratio (SUVR) of the images generated with 18F-PI- 2620, which will be co-registered with the structural magnetic resonance magnetic resonance imaging (MRI) using SPM12 software. The cerebellum will be used as the reference region.
The primary endpoint derived from radiopharmaceutical administration of the radiopharmaceutical will be the Standardized uptake value ratio (SUVR) of the images generated with 18F-PI- 2620, which will be co-registered with the structural magnetic resonance magnetic resonance imaging (MRI) using SPM12 software. The cerebellum will be used as the reference region.
Longitudinal changes in the assessment of neurofibrillary pathology through the Tau tracer (SUVR in Braak regions as defined by Berkeley regions of interest for PI-2620). by Berkeley regions of interest for PI-2620).
Longitudinal changes in the assessment of neurofibrillary pathology through the Tau tracer (SUVR in Braak regions as defined by Berkeley regions of interest for PI-2620). by Berkeley regions of interest for PI-2620).
次要结局
- Correlation of SUVR with longitudinal changes in the assessment of neurofibrillary pathology through Tau tracer neurofibrillary pathology through the Tau tracer (SUVR in Braak regions as defined by Berkeley regions of interest for PI-2620). by Berkeley regions of interest for PI-2620).
- Correlation of SUVR with clinical variables (CAMDEX-DS, CAMCOG) to be obtained from the neuropsychological evaluations.
- Correlation of SUVR with measures of brain atrophy (cortical thickness) as measured by FreeSurfer based on data derived from MRI acquisition.
- Correlation of SUVR with plasma biomarker measurements.
研究者
UICEC Sant Pau
Scientific
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau