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

Phase 1

• Conditions: Alzheimer's disease Down syndrome; MedDRA version: 14.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.0 Level: LLT Classification code 10013616 Term: Down's syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-001564-21-GB
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-01
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

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:
a)statin,
b)fibrates,
c)nicotinic acid,
d)cyclosporine,
e)azole antifungal,
f)itraconazole,
g)ketoconazole,
h)macrolide antibiotics,
i)erythromycin,
j)clarithromycin,
k)fusidic acid,
l)HIV protease inhibitors,
m)nefazodone,
n)verapamil,
o)amiodarone,
p)warfarin.
(10) Having previously had a statin serious adverse reaction.
(11) Unable or unwilling to avoid consumption of grapefruit juice.
(12) Excessive alcohol use (>21 units/week for men, or >14 units/week for women).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified