Status:
UNKNOWN
Assessment of Neural Oscillations in Adult Subjects With Down Syndrome and Typically Developing Subjects in Resting State and While Conducting Cognitive Tasks
Lead Sponsor:
Parc de Salut Mar
Collaborating Sponsors:
Aelis Farma
Starlab
Conditions:
Down Syndrome
Eligibility:
All Genders
18-35 years
Brief Summary
Background: It has been proposed that a hyperactivity of the endocannabinoids system could be involved in the cognitive deficits involved in Down Syndrome (DS). Hyperactivation of the type-1 cannabin...
Eligibility Criteria
Inclusion
- Common
- Weight ≥ 50 kg and ≤ 100 kg
- Body mass index (BMI) ≥ 18.5 and ≤ 30
- TD group additional
- Abstinence for alcohol 72h prior to the screening
- Able to read Spanish and adhere to study requirements.
- Signed informed consent prior to any study-mandated procedure.
- DS group additional
- Clinical diagnosis of Down syndrome (full trisomy 21 and translocations) documented by chromosomal analysis (karyotyping).
- Subject understands and accepts the trial procedures.
- Subject assenting and/or willing to participate.
- Signed informed consent by subject and legal representative prior to any study-mandated procedure.
- Subject independently mobile and have sufficient vision and hearing to participate in study evaluations.
- Abstinence for alcohol 72h prior to the screening.
- Clinical Evaluation of Language Fundamentals Preschool-2 (CELF Preschool-2) test score ≥ 7.
- Subjects must have a parent, or other reliable caregiver who agrees to accompany the subject to all clinic visits, provide information about the subject as required by the protocol, and ensure compliance with study tests.
- Subjects are expected to complete all procedures scheduled during the study visits. They must be able to be understood most of the time and must not use other forms of communication, signs, symbol boards or devices as their primary form of communication.
- TD group
Exclusion
- Substance use disorders except for mild alcohol use disorder and/or mild or moderate nicotine use disorder.
- Testing positive for drugs of abuse in urine at screening or the observation day.
- Lifetime clinically significant cardiovascular, renal, pulmonary, hepatic, onco-hematological, endocrine, gastrointestinal, mental or neurological disease.
- Any other diseases or conditions that in the judgment of the investigator would interfere with the subject's ability to comply with study procedures or requirements and/or study results interpretation.
- Any clinically significant findings in physical examination including vital signs.
- Any prescription or over the counter drug (except occasional use of paracetamol) in the last 2 weeks before Day 1 of each period.
- Patient included in a clinical study with drugs in the last three months.
- DS group
Key Trial Info
Start Date :
January 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04791124
Start Date
January 11 2021
End Date
June 1 2021
Last Update
March 10 2021
Active Locations (1)
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1
IMIM (Hospital del Mar Medical Research Institute)
Barcelona, Spain, 08003