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Clinical Trials/EUCTR2011-001564-21-GB
EUCTR2011-001564-21-GB
Active, not recruiting
Phase 1

Towards Onset Prevention of COGnitive decline in adults with Down syndrome (the TOP-COG study) - The TOP-COG study

HS Greater Glasgow and Clyde0 sites70 target enrollmentAugust 1, 2011
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ConditionsAlzheimer's disease Down syndromeMedDRA version: 14.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.0 Level: LLT Classification code 10013616 Term: Down's syndrome System Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Alzheimer's disease Down syndrome
Sponsor
HS Greater Glasgow and Clyde
Enrollment
70
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2011
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
HS Greater Glasgow and Clyde

Eligibility Criteria

Inclusion Criteria

  • •(1\) Down syndrome.
  • •(2\) Aged \=50\.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 65
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 5

Exclusion Criteria

  • •(1\) No consent obtained.
  • •(2\) Unable to comply with the protocol, including providing blood or saliva for baseline APO E e4 measurement, and venous or capillary blood for cholesterol measurement.
  • •(3\) Dementia at baseline (as the study is investigating primary prevention).
  • •(4\) Diabetes (as this is an indication for a prescription of a statin).
  • •(5\) Clinically evident atherosclerotic disease (as this is an indication for a prescription of a statin).
  • •(6\) Being at risk for cardiovascular disease (as this is an indication for a prescription of a statin).
  • •(7\) Liver disease.
  • •(8\) Chronic renal insufficiency.
  • •(9\) Being prescribed:
  • •b)fibrates,

Outcomes

Primary Outcomes

Not specified

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