Trial Outcomes & Findings for Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease (NCT NCT00359944)

Last Updated: 2013-07-02

Results Overview

Change from baseline to week 16 of the double blind treatment in the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimer's Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

171 participants

Primary outcome timeframe

Baseline to 16 weeks

Results posted on

2013-07-02

Participant Flow

17 patients were excluded from analysis because of QA issues at a study site.

Participant milestones

Participant milestones
Measure	AC-3933, 5 mg AC-3933, 5mg twice daily	AC-3933, 20 mg AC-3933, 20 mg twice daily	Placebo Sugar Pill twice daily
Overall Study STARTED	50	47	57
Overall Study COMPLETED	34	28	38
Overall Study NOT COMPLETED	16	19	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AC-3933 n=43 Participants AC-3933, 5mg twice daily	AC-3933, 20 mg n=40 Participants AC-3933, 20 mg twice daily	Placebo n=49 Participants Sugar Pill twice daily	Total n=132 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	43 Participants n=5 Participants	40 Participants n=7 Participants	49 Participants n=5 Participants	132 Participants n=4 Participants
Age Continuous	75.5 years STANDARD_DEVIATION 8.57 • n=5 Participants	74.8 years STANDARD_DEVIATION 9.54 • n=7 Participants	76.3 years STANDARD_DEVIATION 8.73 • n=5 Participants	75.6 years STANDARD_DEVIATION 8.88 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	27 Participants n=7 Participants	38 Participants n=5 Participants	95 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	37 Participants n=4 Participants
Region of Enrollment United States	43 participants n=5 Participants	40 participants n=7 Participants	49 participants n=5 Participants	132 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 16 weeks

Outcome measures

Outcome measures
Measure	AC-3933, 5 mg n=43 Participants AC-3933, 5mg twice daily	AC-3933, 20 mg n=40 Participants AC-3933, 20 mg twice daily	Placebo n=49 Participants Sugar Pill twice daily
Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)	-1.3 units on a scale Standard Deviation 0.84	-2.9 units on a scale Standard Deviation 0.88	-1.5 units on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Clinicians Interview Based Impression of Change (CIBIC)-Plus-Plus scores at week 16 of the double blind treatment. CIBIC-Plus is ranged between 1 and 7 (1=very much improved, 4=no change, and 7=very much worsened). We were expecting smaller value of CIBIC-Plus at the study end.

Outcome measures

Outcome measures
Measure	AC-3933, 5 mg n=43 Participants AC-3933, 5mg twice daily	AC-3933, 20 mg n=40 Participants AC-3933, 20 mg twice daily	Placebo n=49 Participants Sugar Pill twice daily
Clinicians Interview Based Impression of Change (CIBIC)-Plus	4.1 units on a scale Standard Deviation 0.97	3.9 units on a scale Standard Deviation 1.11	3.9 units on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Change from baseline to week 16 of the double blind treatment in the Disability Assessment for Dementia (DAD) scores. The DAD is administered as a clinician-assisted interview with the caregiver and was developed to assess functional abilities in ADLs in community-dwelling dementia patients. The scale consists of 40 questions assessing basic and instumental ADLs. A total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated N/A are not considered for the total score. Higher scores represent less disability in activities of daily living (ADL) while lower scores indicate more dysfunction.

Outcome measures

Outcome measures
Measure	AC-3933, 5 mg n=43 Participants AC-3933, 5mg twice daily	AC-3933, 20 mg n=40 Participants AC-3933, 20 mg twice daily	Placebo n=49 Participants Sugar Pill twice daily
Disability Assessment for Dementia (DAD)	-2.7 units on a scale Standard Deviation 1.89	4.0 units on a scale Standard Deviation 2.10	4.2 units on a scale Standard Deviation 1.80

Adverse Events

AC-3933, 5 mg

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

AC-3933, 20 mg

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	AC-3933, 5 mg n=50 participants at risk AC-3933, 5mg twice daily	AC-3933, 20 mg n=46 participants at risk AC-3933, 20 mg twice daily	Placebo n=58 participants at risk Sugar Pill twice daily
Psychiatric disorders Anxiety	6.0% 3/50 • Number of events 3 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	2.2% 1/46 • Number of events 1 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	0.00% 0/58 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.
Nervous system disorders Headache	8.0% 4/50 • Number of events 4 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	8.7% 4/46 • Number of events 4 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	1.7% 1/58 • Number of events 1 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.
Nervous system disorders Dizziness	2.0% 1/50 • Number of events 1 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	4.3% 2/46 • Number of events 2 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	8.6% 5/58 • Number of events 5 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.
Infections and infestations Urinary Tract infection	4.0% 2/50 • Number of events 2 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	4.3% 2/46 • Number of events 2 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	8.6% 5/58 • Number of events 5 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.
Investigations Electroencephalogram abnormal	2.0% 1/50 • Number of events 1 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	6.5% 3/46 • Number of events 3 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	6.9% 4/58 • Number of events 4 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.
Gastrointestinal disorders Nausea	4.0% 2/50 • Number of events 2 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	13.0% 6/46 • Number of events 6 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	3.4% 2/58 • Number of events 2 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.
Gastrointestinal disorders Vomiting	2.0% 1/50 • Number of events 1 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	4.3% 2/46 • Number of events 2 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.	5.2% 3/58 • Number of events 3 • February 2006 to September 2008 The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.

Additional Information

Medical Director, CNS

Sunovion

Phone: 1-866-503-6351

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place