Trial Outcomes & Findings for Studying the Effects of Antihypertensives on Individuals at Risk for Alzheimer's (NCT NCT00980785)

Results Overview

CSF Aβ42 levels will be measured from the cerebrospinal fluid taken from subjects on ramipril or placebo at the baseline visit and month 4 and will be measured by Dr. Henrik Zetterberg's laboratory.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

Baseline to 4 months

Results posted on

2020-08-25

Participant Flow

Participants were recruited from the Wisconsin Alzheimer's Disease Research Center (ADRC) registry and from the community for the clinical trial, Studying the Effects of Antihypertensives in Individuals at Risk for Alzheimer's (SEAIRA).

Participant milestones

Participant milestones
Measure	Placebo Matching Placebo Placebo: Matching Placebo	Active Ramipril 5mg/day Ramipril: Ramipril 5 mg/day
Overall Study STARTED	6	8
Overall Study COMPLETED	6	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Studying the Effects of Antihypertensives on Individuals at Risk for Alzheimer's

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=6 Participants Matching Placebo Placebo: Matching Placebo	Active n=8 Participants Ramipril 5mg/day Ramipril: Ramipril 5 mg/day	Total n=14 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	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	52.0 years STANDARD_DEVIATION 6.7 • n=5 Participants	56.3 years STANDARD_DEVIATION 6.1 • n=7 Participants	54.2 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 4 months

CSF Aβ42 levels will be measured from the cerebrospinal fluid taken from subjects on ramipril or placebo at the baseline visit and month 4 and will be measured by Dr. Henrik Zetterberg's laboratory.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Matching Placebo Placebo: Matching Placebo	Active n=8 Participants Ramipril 5mg/day Ramipril: Ramipril 5 mg/day
Change in Cerebrospinal Fluid (CSF) Amyloid Beta-42 (Aβ42) Levels Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo	-22.5 pg/ml Standard Deviation 78.7	-31.71 pg/ml Standard Deviation 90.6

SECONDARY outcome

Timeframe: Baseline to 4 months

CSF ACE levels will be measured from the cerebrospinal fluid taken from subjects on Ramipril or placebo at the baseline visit and month 4 and will be measured by ARUP® laboratories by spectrophotometric enzymatic assay.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Matching Placebo Placebo: Matching Placebo	Active n=8 Participants Ramipril 5mg/day Ramipril: Ramipril 5 mg/day
Change in CSF Angiotensin Converting Enzyme (ACE) Levels Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo	-0.10 U/L Standard Deviation 0.21	-0.63 U/L Standard Deviation 0.32

SECONDARY outcome

Timeframe: Baseline to 4 months

FMD is calculated as the ratio of brachial artery diameter after reactive hyperemia to baseline diameter, expressed as percentage change. FMD for each subject (ramipril v placebo) will be measured at baseline and month 4, observing any differences.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Matching Placebo Placebo: Matching Placebo	Active n=8 Participants Ramipril 5mg/day Ramipril: Ramipril 5 mg/day
Change in Flow-mediated Vasodilation (FMD) Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo	-0.70 Percentage change Standard Deviation 1.56	-0.29 Percentage change Standard Deviation 1.23

SECONDARY outcome

Timeframe: Baseline to 4 months

Pulse wave velocity was measured using an AtCor SphymoCor Px tonometry system. A small pressure transducer was placed on the skin at the point the arterial pulsation of the right common carotid and right radial arteries. A Millar micromanometer is in the tip of the probe. Using a generalized transfer function, the distance between these pressure points, and the peripheral arterial waveforms, a central aortic pressure signal is derived, from which aortic augmentation index is determined.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Matching Placebo Placebo: Matching Placebo	Active n=8 Participants Ramipril 5mg/day Ramipril: Ramipril 5 mg/day
Change in Augmentation Index (%) Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo	1.7 Percentage change Standard Deviation 8.9	-1.8 Percentage change Standard Deviation 2.2

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cynthia M. Carlsson, MD, MS

University of Wisconsin School of Medicine and Public Health

Phone: 608-256-1901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place