GnRH Therapy on Cognition in Down Syndrome
关键词
抽象
日期
最后验证: | 04/30/2020 |
首次提交: | 05/04/2020 |
提交的预估入学人数: | 05/12/2020 |
首次发布: | 05/14/2020 |
上次提交的更新: | 05/12/2020 |
最近更新发布: | 05/14/2020 |
实际学习开始日期: | 05/31/2020 |
预计主要完成日期: | 11/30/2023 |
预计完成日期: | 02/29/2024 |
状况或疾病
干预/治疗
Drug: Pulsatile GnRH pump treatment
Drug: Pulsatile placebo pump treatment
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Pulsatile GnRH pump treatment | Drug: Pulsatile GnRH pump treatment Drug administered by a subcutaneous pump during 24 weeks, at a dosage of 75 ng/kg/pulse giving a pulse every 90 minutes in women and every 120 minutes in men. |
Placebo Comparator: Pulsatile placebo pump treatment | Drug: Pulsatile placebo pump treatment Drug administered by a subcutaneous pump during 24 weeks, at a dosage of 75 ng/kg/pulse giving a pulse every 90 minutes in women and every 120 minutes in men. |
资格标准
有资格学习的年龄 | 20 Years 至 20 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Diagnosis of trisomy 21 - Ability to follow the procedures of the study - Olfactory impairment (Sniffin' Sticks, identification score: for men ≤11, for women ≤12) - Consent to a non-hormonal contraception during the whole duration of the study Exclusion Criteria: - Clinical or biochemical findings suggesting acute illness/hospitalization - Chronic alcohol abuse, illicit drug use, or anabolic steroid abuse - Pituitary adenoma and other hormone-dependent tumours - Participation in another clinical study - Intention to become a parent during the course of the study - Pregnant or breastfeeding women - Participant or his/her legal representative do not want to be informed in case of incidental findings |
结果
主要结果指标
1. Cognition [Baseline to end of treatment (Week 24)]
次要成果指标
1. Olfaction [baseline to Week 12, and to the end of treatment (Week 24)]
2. Amyloidosis [baseline to Week 12, and to the end of treatment (Week 24)]
3. Brain MRI [baseline to the end of treatment (Week 24)]
4. Health-related quality of life (HRQoL) [baseline to Week 4, 12, and to the end of treatment (Week 24)]
其他成果措施
1. Glycemia [baseline to Week 12, and to the end of treatment (Week 24)]
2. Insulinemia [baseline to Week12, and to the end of treatment (Week 24)]
3. Leptinemia [baseline to Week 12, and to the end of treatment (Week 24)]
4. Glycated hemoglobin (HbA1c) [baseline to Week 24]
5. Interleukin-6 (IL-6) [baseline to Week 24]
6. Interferon-alfa (IFN-a) [baseline to Week 24]
7. Tumor necrosis factor- alfa (TNF-a) [baseline to Week 24]
8. Total cholesterol [baseline to Week 24]
9. High density lipoprotein (HDL)-cholesterol [baseline to Week 24]
10. Low density lipoprotein (LDL)-cholesterol [baseline to Week 24]
11. Triglycerides [baseline to Week 24]