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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001564-21-GB

Enrollment

Registered

2011-08-01

Start date

2011-09-19

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 geneti

Interventions

Product Name: Simvastatin Pharmaceutical Form: Capsule INN or Proposed INN: Simvastatin CAS Number: 79902-63-9 Current Sponsor code: Not

Eligibility

Sex/Gender

All

Inclusion 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

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).

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 3, 6 and 12 months; Main Objective: The aims of the study are to gather the data needed to design a full-scale multi-centred RCT of oral simvastatin 40mg a day. The principal research questions are: What are the: (1) trial recruitment/retention rates and recruitment sources, (2) rates of tolerability/safety of oral simvastatin 40mg a day, (3) most sensitive instruments to detect early cognitive decline in adults with Down syndrome, and (4) perceptions of adults with Down syndrome and their carers on deciding whether to participate, on randomisation, and their experience of the assessments? ; Secondary Objective: The secondary reserach questions are: (5) what are the distributions of the primary (cognitive decline) and key secondary (adative behavior, general health/quality of life, service use, carer strain) outcome measures that would be used in a definitive RCT, and what are the sample size implications of these distributions, (6) is Aß42/Aß40 a biomarker for cognitive decline, and (7) do the results support proceeding to a full RCT? ; Primary end point(s): 1: Feasibility (1) The numbers screened and recruited each month over the 6 month recruitment period. (2) The retention of participants in the study after 12 months. (3) The percentage of the total recruited from each source, and the number of contacts with each source to achieve this. The source will be identified at the initial telephone call to assess suitability to invite the person to participate. The number of contacts will be identified through the researcher and the SPCRN recording each one on a contact recording sheet. (4) The number recruited per base general population siz	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 3, 6 and 12 months; Main Objective: The aims of the study are to gather the data needed to design a full-scale multi-centred RCT of oral simvastatin 40mg a day. The principal research questions are: What are the: (1) trial recruitment/retention rates and recruitment sources, (2) rates of tolerability/safety of oral simvastatin 40mg a day, (3) most sensitive instruments to detect early cognitive decline in adults with Down syndrome, and (4) perceptions of adults with Down syndrome and their carers on deciding whether to participate, on randomisation, and their experience of the assessments? ; Secondary Objective: The secondary reserach questions are: (5) what are the distributions of the primary (cognitive decline) and key secondary (adative behavior, general health/quality of life, service use, carer strain) outcome measures that would be used in a definitive RCT, and what are the sample size implications of these distributions, (6) is Aß42/Aß40 a biomarker for cognitive decline, and (7) do the results support proceeding to a full RCT? ; Primary end point(s): 1: Feasibility (1) The numbers screened and recruited each month over the 6 month recruitment period. (2) The retention of participants in the study after 12 months. (3) The percentage of the total recruited from each source, and the number of contacts with each source to achieve this. The source will be identified at the initial telephone call to assess suitability to invite the person to participate. The number of contacts will be identified through the researcher and the SPCRN recording each one on a contact recording sheet. (4) The number recruited per base general population siz

—

Secondary

Measure	Time frame
Secondary end point(s): 1: Effect size after 12 months simvastatin/placebo (1) cognitive decline (2) skill decline (3) general health/quality of life (4) service use and social changes 2: Biomarkers (1) Abeta40/Abeta42 ;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026