Trial Outcomes & Findings for Simvastatin for mTBI (NCT NCT01952288)

NCT ID: NCT01952288

Last Updated: 2021-12-15

Results Overview

Change in CSF total tau concentration from baseline to 12 months of study drug treatment

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 5 participants
• Primary outcome timeframe: baseline, 12 months
• Results posted on: 2021-12-15

Participant Flow

Participant milestones

Measure	Simvastatin simvastatin 40 mg/day simvastatin: simvastatin 40 mg/day for 12 months	Placebo placebo Placebo Oral Tablet: placebo comparator
Overall Study STARTED	3	2
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Simvastatin for mTBI

Baseline characteristics by cohort

Measure	Simvastatin n=3 Participants simvastatin 40 mg/day simvastatin: simvastatin 40 mg/day for 12 months	Placebo n=2 Participants placebo Placebo Oral Tablet: placebo comparator	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 12 months

Change in CSF total tau concentration from baseline to 12 months of study drug treatment

Outcome measures

Measure	Simvastatin n=3 Participants simvastatin 40 mg/day simvastatin: simvastatin 40 mg/day for 12 months	Placebo n=2 Participants placebo Placebo Oral Tablet: placebo comparator
Cerebrospinal Fluid (CSF) T-tau Concentration	24 pg/ml Standard Error 20	33.5 pg/ml Standard Error 17

PRIMARY outcome

Timeframe: baseline, 12 months

Change in CSF p-tau 181 concentration from baseline to 12 months of study drug treatment

Outcome measures

Measure	Simvastatin n=3 Participants simvastatin 40 mg/day simvastatin: simvastatin 40 mg/day for 12 months	Placebo n=2 Participants placebo Placebo Oral Tablet: placebo comparator
Cerebrospinal Fluid (CSF) P-tau 181 Concentration	3.1 pg/ml Standard Error 2	1.6 pg/ml Standard Error 1.4

SECONDARY outcome

Timeframe: baseline, 12 months

change in CSF abeta 1-40 concentration from baseline to 12 months of study drug treatment

Outcome measures

Measure	Simvastatin n=3 Participants simvastatin 40 mg/day simvastatin: simvastatin 40 mg/day for 12 months	Placebo n=2 Participants placebo Placebo Oral Tablet: placebo comparator
CSF Abeta 1-40 Concentration	753 pg/ml Standard Error 363	953 pg/ml Standard Error 710

SECONDARY outcome

Timeframe: baseline, 12 months

change in CSF abeta 1-42 concentration from baseline to 12 months of study drug treatment

Outcome measures

Measure	Simvastatin n=3 Participants simvastatin 40 mg/day simvastatin: simvastatin 40 mg/day for 12 months	Placebo n=2 Participants placebo Placebo Oral Tablet: placebo comparator
CSF Abeta 1-42 Concentration	43 pg/ml Standard Error 24.5	82.5 pg/ml Standard Error 58.5

Adverse Events

Simvastatin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Simvastatin n=3 participants at risk simvastatin 40 mg/day simvastatin: simvastatin 40 mg/day for 12 months	Placebo n=2 participants at risk placebo Placebo Oral Tablet: placebo comparator
Infections and infestations Upper Respiratory Infection	66.7% 2/3 • Number of events 2 • baseline through 12 months study participation	0.00% 0/2 • baseline through 12 months study participation
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 2 • baseline through 12 months study participation	50.0% 1/2 • Number of events 2 • baseline through 12 months study participation
Nervous system disorders Increased Confusion	33.3% 1/3 • Number of events 1 • baseline through 12 months study participation	0.00% 0/2 • baseline through 12 months study participation
General disorders nasal congestion	33.3% 1/3 • Number of events 1 • baseline through 12 months study participation	0.00% 0/2 • baseline through 12 months study participation
Infections and infestations Tonsillitis	33.3% 1/3 • Number of events 1 • baseline through 12 months study participation	0.00% 0/2 • baseline through 12 months study participation
Musculoskeletal and connective tissue disorders Sciatica	33.3% 1/3 • Number of events 1 • baseline through 12 months study participation	0.00% 0/2 • baseline through 12 months study participation
General disorders night sweats	0.00% 0/3 • baseline through 12 months study participation	50.0% 1/2 • Number of events 1 • baseline through 12 months study participation
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/3 • baseline through 12 months study participation	50.0% 1/2 • Number of events 1 • baseline through 12 months study participation
Musculoskeletal and connective tissue disorders Shoulder pain	33.3% 1/3 • Number of events 1 • baseline through 12 months study participation	0.00% 0/2 • baseline through 12 months study participation

Additional Information

Rebekah J. Rein, JD

VA Puget Sound Health Care System

Phone: 206-764-2711

Email: rebekah.rein@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place