Down Syndrome (DS)

11

Review clinical trials related to Down Syndrome (DS). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

NAD Augmentation to Prevent or Reverse Alzheimer's Disease in People With Down Syndrome

The aim of the study is to determine the safety and tolerability of different increasing doses of MIB-626 (a microcrystalline form of β nicotinamide mononucleotide; NMN) given daily for 28 consecutive days to adults with Down syndrome (DS). The study will also explore how the drug moves through the body over time (pharmacokinetics or PK) and how the drug affects the body in different ways (pharmacodynamics or PD). The study participants will be monitored for adverse events and measurements to detect safety events will take place including laboratory tests of blood counts, chemistries and coagulation profile, and electrocardiogram (ECG). The trial will enroll a total of 24 adults with DS who are 18 years or older and are medically stable. People enrolled in the study will be randomly assigned to receive either the active intervention (MIB-626) tablets, or placebo tablets for 28 days. Study participants will be followed for an additional 28 days (total 56 days of follow-up). This study will also explore the effect of MIB-626 on different measures associated with aging and risk of Alzheimer's Disease (AD).

Participants needed: 24
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Brigham and Women's HospitalUpdated: Jun 25, 2026Locations: 2
Eligibility criteria

A diagnosis of full trisomy for chromosome 21 or complete unbalanced translocati... [+4]

Fasting morning UACR > 5,000 mg/ g creatinine [+11]

Status: Not yet recruiting

Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation

The goal of this clinical trial is to learn if donanemab can reduce levels of amyloid in the brain, and if donanemab is safe and well-tolerated in participants with Down syndrome. The main questions it aims to answer are: Does donanemab reduce amyloid in the brain? Is donanemab safe and well-tolerated in people with Down syndrome? Researchers will compare donanemab to a placebo (a look-alike substance that contains no drug) to see if donanemab works to reduce levels of amyloid in the brain. Participants in the study will be 35-50 years old and will be in the study for 12 months. Participants will then stay in the study for an additional 12 months in an long-term extension where all participants will receive donanemab. Participants who had a reduction in amyloid (measured by amyloid brain scan) by the end of the first 12 months will receive placebo for the long-term extension, while participants who did not have an amyloid reduction will receive study donanemab for the long-term extension. Everyone (participants and study staff) will remain blinded to treatment for the duration of the study. Participants will: * Have intravenous (IV) infusions of donanemab (or placebo) every 4 weeks * Visit the clinic once every other month for checkups and tests. These tests will include brain scans (magnetic resonance imaging \[MRI\] and positron emission tomography \[PET\] ), blood draws and memory tests. * Have a study partner who who can provide information about the participant and can join participant for some of the study visits.

Participants needed: 60
Trial details
Phase: Phase 4Age: 35-50Biological sex: AllType: InterventionalSponsor: Michael Rafii, MD, PhDUpdated: May 15, 2026
Eligibility criteria

Documentation of the participant's informed consent to study procedures [+10]

Females who are lactating or pregnant (as confirmed by a urine pregnancy test) d... [+37]

Status: Recruiting

Adapting RDAD for DS

The goal of this clinical trial is to observe feasibility and initial efficacy of a remotely delivered exercise and dementia caregiving intervention in older adults with Down syndrome and their caregivers.

Participants needed: 40
Trial details
Biological sex: AllType: InterventionalSponsor: University of Kansas Medical CenterUpdated: May 6, 2026Locations: 1
Eligibility criteria

Age >35 yrs. with a diagnosis of DS as self-reported or reported by caregiver. T... [+3]

Unable to participate in moderate-to-vigorous physical activity. [+7]

Status: Recruiting

Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome

The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred. CXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day. It is designed to stop the progression of disease by strengthening the cornea. Study participants will be 8 years of age or older and have a diagnosis of Down syndrome. The main question it aims to answer is: * Does CXL help prevent or slow the progression of someone's corneal condition and vision loss? Participants will: * Attend up to a total of 7 in office visits over the course of 6 months, where several eye and vision tests will be given. Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light for 20 minutes).

Participants needed: 225
Trial details
Phase: Phase 3Age: 8+Biological sex: AllType: InterventionalSponsor: Woolfson Eye InstituteUpdated: Feb 2, 2026Locations: 12
Eligibility criteria

Be at least 8 years of age or older, male or female, of any race. [+5]

Normal corneal topography. [+7]

Status: Recruiting

Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome

Purpose: This study will test whether 8 weeks of creatine and HMB supplementation can improve muscle strength, body composition, balance, and overall health in people with Down syndrome. Participants will also receive nutrition tips during the study. Who can participate: People with Down syndrome who can perform basic physical tasks. Must provide consent from the participant and legal guardian. What participants will do: Take creatine (3 g/day) and HMB (3 g/day) or placebo for 8 weeks. Complete tests for muscle strength, balance, and cognitive function. Undergo body composition scans and give blood samples for health markers. Timing: All tests and blood samples are taken before and after each 8-week period. Importance: Results will help determine if creatine and HMB can safely improve strength, balance, and overall health in people with Down syndrome.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Universidad de BurgosUpdated: Jan 14, 2026Locations: 1
Eligibility criteria

Diagnosis: Medical confirmation of Down syndrome (trisomy of chromosome 21). [+2]

Chronic kidney disease: Diagnosis of chronic kidney disease. [+3]

Status: Recruiting

LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome

The purpose of this study is to evaluate whether levetiracetam can prevent epileptic seizures in patients with Alzheimer's disease associated with Down syndrome. It will also analyze whether it can delay the neurodegeneration associated with this disease. Patients will be randomly assigned to one of two groups: one group will receive the active drug (levetiracetam), and the other will receive a placebo. Both groups will receive the treatment for 96 weeks. Each patient will participate for a total of 2 years and 5 months.

Participants needed: 120
Trial details
Phase: Phase 3Age: 40+Biological sex: AllType: InterventionalSponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUpdated: Jan 12, 2026Locations: 5
Eligibility criteria

Diagnosed with Down Syndrome (DS), either with a karyotype or a compatible typic... [+5]

Subjects and/or their caregivers must be able to provide their consent before pa... [+11]

Status: Recruiting

The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia

This prospective non-randomized multicenter trial created based on protocol ML DS 2006 and aimed at standardization of current therapy approaches and creating a national network for diagnostic, treatment and monitoring of children (0-18 years) with AML and Down syndrome in Russia. Based on the results the investigators expect to increase long-term overall and event-free survival in children with AML and DS and reduce the immediate and remote toxicity of chemotherapy by reducing the dose load of chemotherapeutic drugs. The study protocol therapy for all patients includes four chemotherapy blocks: Course 1 AIE (cytarabine/idarubicin/etoposide) Course 2 AI (cytarabine/idarubicin) Course 3 HAD (high -dose cytarabine (1g)/daunorubicin) Course 4 HA (high-dose cytarabine) Safety to be monitored based on CTCAE v5.0

Participants needed: 100
Trial details
Phase: Phase 3Age: 1-18Biological sex: AllType: InterventionalSponsor: Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUpdated: Nov 20, 2025Locations: 1
Eligibility criteria

Age 0-18 years [+2]

Children with Down syndrome and acute lymphoblastic leukemia (ALL) [+3]

Status: Recruiting

The Effect of the HEP Approach in Infants With Down Syndrome

This study evaluates the effect of the HEP (Homeostasis-Enrichment-Plasticity) approach on motor and sensory development in infants with Down syndrome. Thirty-two infants will receive either HEP or traditional therapy over 12 sessions, and outcomes will be measured using standardized developmental tests.

Participants needed: 26
Trial details
Age: 4-12Biological sex: AllType: InterventionalSponsor: Izgi Miray DemirbagUpdated: Nov 14, 2025Locations: 1
Eligibility criteria

Must be between 4 and 12 months old [+3]

History of intraventricular hemorrhage (Grade III or IV) [+4]

Status: Recruiting

Using Technologies to Promote HEalthy Lifestyles in Adolescents With Intellectual Disabilities

IDHEApp will implement various educational technology tools and work with the families, teachers and caregivers to increase physical activity (PA) and improve healthy eating. Due to the current COVID-19 pandemic restrictions, the use of innovative digital technology can contribute not just to distance learning but also to support families and students in remote. However, both healthy habits and technologies are insufficiently addressed in the population with IDD. These needs are in line with the following objectives of the Erasmus+ programme: a) Inclusion and diversity in all fields of education, training, youth and sport; b) Addressing digital transformation through development of digital readiness, resilience and capacity, and c) Encouraging the participation in sport and physical activity. Educators will find innovative possibilities and the right instruments that will enable them to fulfil their potential through innovative online education \& learning \& training skills module for lifestyle promotion and others available on the app. Furthermore, mentors and others health professionals (e.g., nursing etc.) will be equipped with knowledge and skills on how to use the app to teach practical skills for PA enhancement in an evidence-based way. Consequently, this project will contribute to \[specific objectives - SO\]: \- Raise awareness of the importance of healthy and active living among young Europeans with intellectual disabilities. Different workshops and bigger events (i.e., international conference), together with the involvement of numerous participants from the institutions of this consortium will be ensured. Further, a sensitized community will participate through the social networks and the website itself, in the proposed activities. \- Provide digital resources and tools to the partner entities of the exchange to improve lifestyle of young people with intellectual disabilities. Best Practices to provide high quality, inclusive digital health education with the best educational technology tools and methodology. A website, a mobile app and different electronic guidelines will be delivered. \- Analyze the current state of use and acceptance of technologies as support in the management of health in adolescent with intellectual disabilities.

Participants needed: 60
Trial details
Age: 4-30Biological sex: AllType: InterventionalSponsor: University of SevilleUpdated: Aug 7, 2025Locations: 1
Eligibility criteria

Diagnosis of intellectual disability [+2]

presence of severe sensory or motor impairments [+2]

Status: Recruiting

Pediatric Down Syndrome Post-Approval Study

The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.

Participants needed: 60
Trial details
Age: 13-18Biological sex: AllType: InterventionalSponsor: Inspire Medical Systems, Inc.Updated: Feb 28, 2025Locations: 6
Eligibility criteria

Patient has been diagnosed with Down syndrome; [+6]

Patient's recent PSG (within 6 months of enrollment) reports central + mixed apn... [+8]

Status: Recruiting

Suspension Therapy Effects on Mobility and Balance in Down Syndrome

Down syndrome (DS) is one of the most common congenital disorders. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. These factors are responsible for the developmental challenges faced by children with Down syndrome. These individuals also present with balance dysfunctions. Neuromuscular and musculoskeletal impairments due to the chromosomal abnormality lead to developmental delay. These children also exhibit poor balance with greater instability and inefficient compensatory mechanisms including altered center of pressure displacement and trunk stiffening that predisposes them to falls. The aim of this study is to determine the Effects of Suspension Therapy (ST) on mobility and balance of children with Down syndrome. Suspension Therapy using Universal exercise Unit (UEU) is a three dimensional (3D) cage, consists of system of pulleys, suspensions, belts for supporting and elastic cords. Suspension Therapy is based on the concept of unloading the body against gravity and to perform movement of weak part of body.

Participants needed: 26
Trial details
Age: 3-6Biological sex: AllType: InterventionalSponsor: Riphah International UniversityUpdated: Dec 27, 2024Locations: 2
Eligibility criteria

Aged between 3 to 6 years [+3]

Visual and Hearing impairment [+1]