Trial Outcomes & Findings for Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders (NCT NCT01333098)

Results Overview

number of participants with dose-limiting side effects

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Baseline, Week 2, Week 4

Results posted on

2020-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Mifepristone 1 week mifepristone or placebo, followed by 3 weeks open label mifepristone Mifepristone: 300mg per day, by mouth, for 21-28 days
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mifepristone n=15 Participants 1 week mifepristone or placebo followed by 3 weeks open label mifepristone Mifepristone: 300mg per day, by mouth, for 21-28 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	73.1 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4

number of participants with dose-limiting side effects

Outcome measures

Outcome measures
Measure	Mifepristone n=15 Participants 1 week mifepristone or placebo, followed by 3 weeks open label mifepristone Mifepristone: 300mg per day, by mouth, for 21-28 days	Without High Baseline Corisol baseline peak cortisol \<6 ng/ml
Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects	1 Participants	—

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Mifepristone n=15 Participants 1 week mifepristone or placebo, followed by 3 weeks open label mifepristone Mifepristone: 300mg per day, by mouth, for 21-28 days	Without High Baseline Corisol baseline peak cortisol \<6 ng/ml
Number of Participants With Self-reported Side Effects dizziness	5 participants with reported side effects	—
Number of Participants With Self-reported Side Effects fatigue	3 participants with reported side effects	—
Number of Participants With Self-reported Side Effects nausea	2 participants with reported side effects	—

PRIMARY outcome

Timeframe: Baseline, Week 4, Week 12

Memory composite z-score: The two memory measures were a 16-word list recall similar to the Rey auditory verbal learning test, which has been used by the Washington University Alzheimer's Disease Research Center; and two paragraphs from a set of paragraph recall tests validated as sensitive to effects of stress-level glucocorticoids. For each memory variable, a z score was computed for each participant, where z score = (participant score mean)/standard deviation. Then a single composite memory variable was created by summing up these z scores. Summed Z-scores range from -6 to 6, with scores above 0 being higher than the mean.

Outcome measures

Outcome measures
Measure	Mifepristone n=5 Participants 1 week mifepristone or placebo, followed by 3 weeks open label mifepristone Mifepristone: 300mg per day, by mouth, for 21-28 days	Without High Baseline Corisol n=8 Participants baseline peak cortisol \<6 ng/ml
Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures. Baseline	0.93 z-score Standard Error 1.58	-0.59 z-score Standard Error 1.24
Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures. Week 4	1.85 z-score Standard Error 1.97	-0.45 z-score Standard Error 1.34
Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures. Week 12	3.00 z-score Standard Error 2.20	-0.26 z-score Standard Error 1.42

SECONDARY outcome

Timeframe: baseline, week 4, week 12

Self-report assessment of worry using Penn State Worry Questionnaire- Abbreviated, an 8-item measure (range 8-40 with high scores indicating higher levels of anxiety and worry symptoms.The average score for older adults with generalized anxiety disorder is 22, while the mean score for healthy older adults is 15.

Outcome measures

Outcome measures
Measure	Mifepristone n=5 Participants 1 week mifepristone or placebo, followed by 3 weeks open label mifepristone Mifepristone: 300mg per day, by mouth, for 21-28 days	Without High Baseline Corisol n=8 Participants baseline peak cortisol \<6 ng/ml
Anxiety Symptoms Baseline	30.80 Scores on a scale Standard Error 4.27	27.88 Scores on a scale Standard Error 1.85
Anxiety Symptoms Week 4	22.40 Scores on a scale Standard Error 6.09	27.00 Scores on a scale Standard Error 1.51
Anxiety Symptoms Week 12	23.0 Scores on a scale Standard Error 6.02	25.29 Scores on a scale Standard Error 2.39

Adverse Events

Mifepristone

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mifepristone n=15 participants at risk 1 week mifepristone or placebo (followed by 3 weeks open label mifepristone) Mifepristone: 300mg per day, by mouth, for 21-28 days
Blood and lymphatic system disorders Neutropenia	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the course of each participant's 12 week participation in the study which took place during a 4 month period.
Blood and lymphatic system disorders Hypokalemia	13.3% 2/15 • Number of events 2 • Adverse event data was collected during the course of each participant's 12 week participation in the study which took place during a 4 month period.
Endocrine disorders Reduced T4	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the course of each participant's 12 week participation in the study which took place during a 4 month period.
Cardiac disorders Worsening of pre-existing orthostatic hypotension	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the course of each participant's 12 week participation in the study which took place during a 4 month period.

Additional Information

Eric Lenze, MD

Washington University School of Medicine

Phone: 314-362-5154

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place