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Sleep and body temperature as markers of progression of Alzheimer's disease in Down syndrome.
EU CTIS ID: 2023-506609-21-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.).
- Pregnancy.
- 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
See the full eligibility criteria
- 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.
- 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.).
- Pregnancy.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.