2023-506609-21-00RecruitingPhase 2
Sleep and body temperature as markers of progression of Alzheimer's disease in Down syndrome.
Sleep and Temperature Disturbance as risk factors for Alzheimer's Disease in Down Syndrome: a Longitudinal Study.
This trial only enrols participants with Down syndrome
Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Sept 2023
- Start date
- 9 Apr 2024
- Lead sponsor
- Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
- Diseases
- Alzheimer disease
- EU CT number
- 2023-506609-21-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 to 60 with Down syndrome and mild or moderate intellectual disability, in good general health. It studies sleep and body temperature as signs of Alzheimer's disease progression.
- Age
- 40 to 60 years
- Sex
- Women and men can both join.
- Disease stage
- Down syndrome confirmed by karyotyping. Intellectual disability must be mild or moderate, so the person can complete the CAMCOG cognitive tests.
- Earlier treatment
- No new psychoactive drugs in the 3 months before the study. No current sedatives or sleeping pills, stimulants, antipsychotics, gabapentin, pregabalin, tricyclic antidepressants, trazodone or other psychoactive drugs that may change sleep or body temperature.
Main reasons for not taking part
- Cannot give informed consent
- Significant unstable medical or psychiatric illness
- Reasons that make an MRI unsafe, such as claustrophobia, a pacemaker or an aneurysm clip
- Pregnancy
- Irregular sleep cycles or an extreme mismatch of the body clock lasting 3 months or more
This trial only enrols participants with Down syndrome. The registry sentence this rests on: Subjects with Down syndrome of both sexes between 40 and 60 years.
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Use of new psychoactive drugs in the three months prior to the study.
Other illness
- Any significant unstable medical or psychiatric condition or disease.
- Psychiatric illnesses that may affect cognition, such as bipolar disorder or schizophrenia, or the use of medications or substance abuse.
- Gastrointestinal conditions that may present a risk of bowel wall protrusion.
- 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.
Other
- Inability to give informed consent.
- Common contraindications for MRI (claustrophobia, pacemaker, aneurysm clip, etc.). aneurysm clip, etc.).
- Pregnancy.
- Irregular sleep cycles, extremely long or short total sleep duration and extreme unstable circadian mismatch (3 months or more).
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.