Sleep and body temperature as markers of progression of Alzheimer's disease in Down syndrome.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

9 Apr 2024 → ongoing

Decision date (initial)

2024-01-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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.

Secondary objectives 1

1. The administration of the radiotracer 18F-PI-2620 will be performed for the detection of tau pathology as one of the biomarkers of Alzheimer's disease associated with Down syndrome.

Conditions and MedDRA coding

Down Syndrome.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Subjects with Down syndrome of both sexes between 40 and 60 years.
2. With a degree of intellectual disability that allows completing the CAMCOG cognitive battery.mild or moderate.
3. Diagnosis of Down syndrome confirmed by karyotyping.
4. Patients with good general health.

Exclusion criteria 10

1. Inability to give informed consent.
2. Common contraindications for MRI (claustrophobia, pacemaker, aneurysm clip, etc.). aneurysm clip, etc.).
3. Pregnancy.
4. Psychiatric illnesses that may affect cognition, such as bipolar disorder or schizophrenia, or the use of medications or substance abuse.
5. 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
6. Gastrointestinal conditions that may present a risk of bowel wall protrusion.
7. Use of new psychoactive drugs in the three months prior to the study.
8. Irregular sleep cycles, extremely long or short total sleep duration and extreme unstable circadian mismatch (3 months or more).
9. 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.
10. Any significant unstable medical or psychiatric condition or disease.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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.
2. 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).

Secondary endpoints 4

1. 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).
2. Correlation of SUVR with clinical variables (CAMDEX-DS, CAMCOG) to be obtained from the neuropsychological evaluations.
3. Correlation of SUVR with measures of brain atrophy (cortical thickness) as measured by FreeSurfer based on data derived from MRI acquisition.
4. Correlation of SUVR with plasma biomarker measurements.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Sponsor organisation

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Address

Calle De San Quintin 77-79

City

Barcelona

Postcode

08041

Country

Spain

Scientific contact point

Organisation

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Contact name

UICEC Sant Pau

Public contact point

Organisation

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Contact name

UICEC Sant Pau

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications