Trial Outcomes & Findings for Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment. (NCT NCT00040443)
NCT ID: NCT00040443
Last Updated: 2018-07-23
Results Overview
The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI. The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled.
COMPLETED
PHASE2
175 participants
28 Days
2018-07-23
Participant Flow
Participant milestones
| Measure |
CX516
CX516 - 900 mg
CX516 (Ampalex®)
|
Placebo
Placebo to CX516 900 mg
CX516 (Ampalex®)
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
91
|
|
Overall Study
COMPLETED
|
84
|
91
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
Baseline characteristics by cohort
| Measure |
CX516
n=84 Participants
CX516 - 900 mg
CX516 (Ampalex®)
|
Placebo
n=91 Participants
Placebo to CX516 900 mg
CX516 (Ampalex®)
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.0 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
70.3 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
71.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: Intent to Treat (ITT)
The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI. The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled.
Outcome measures
| Measure |
CX516
n=84 Participants
CX516 - 900 mg (3 X 300 mg)
CX516 (Ampalex®)
|
Placebo
n=91 Participants
Placebo to CX516 300 mg
CX516 (Ampalex®)
|
|---|---|---|
|
15-Item Word List Delayed Recall
|
-0.3 units on a scale - change from baseline
Standard Deviation 2.3
|
-0.5 units on a scale - change from baseline
Standard Deviation 2.3
|
Adverse Events
CX516
Placebo
Serious adverse events
| Measure |
CX516
n=84 participants at risk
CX516 - 900 mg (3 X 300 mg)
CX516 (Ampalex®)
|
Placebo
n=91 participants at risk
Placebo to CX516 300 mg
CX516 (Ampalex®)
|
|---|---|---|
|
Blood and lymphatic system disorders
neutrophil count decrease
|
1.2%
1/84 • Number of events 1 • 28 Day treatment 8 week followup
|
0.00%
0/91 • 28 Day treatment 8 week followup
|
|
Infections and infestations
moderate urinary tract infection
|
1.2%
1/84 • Number of events 1 • 28 Day treatment 8 week followup
|
0.00%
0/91 • 28 Day treatment 8 week followup
|
|
Cardiac disorders
angina pectoris
|
1.2%
1/84 • Number of events 1 • 28 Day treatment 8 week followup
|
0.00%
0/91 • 28 Day treatment 8 week followup
|
|
Cardiac disorders
Chest pain
|
0.00%
0/84 • 28 Day treatment 8 week followup
|
1.1%
1/91 • Number of events 1 • 28 Day treatment 8 week followup
|
Other adverse events
| Measure |
CX516
n=84 participants at risk
CX516 - 900 mg (3 X 300 mg)
CX516 (Ampalex®)
|
Placebo
n=91 participants at risk
Placebo to CX516 300 mg
CX516 (Ampalex®)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
4.8%
4/84 • Number of events 4 • 28 Day treatment 8 week followup
|
2.2%
2/91 • Number of events 2 • 28 Day treatment 8 week followup
|
|
General disorders
Fatigue
|
7.1%
6/84 • Number of events 6 • 28 Day treatment 8 week followup
|
4.4%
4/91 • Number of events 4 • 28 Day treatment 8 week followup
|
|
Infections and infestations
Urinary Tract Infections
|
3.6%
3/84 • Number of events 3 • 28 Day treatment 8 week followup
|
0.00%
0/91 • 28 Day treatment 8 week followup
|
|
Investigations
Creatinin increased
|
4.8%
4/84 • Number of events 4 • 28 Day treatment 8 week followup
|
1.1%
1/91 • Number of events 1 • 28 Day treatment 8 week followup
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/84 • Number of events 1 • 28 Day treatment 8 week followup
|
4.4%
4/91 • Number of events 4 • 28 Day treatment 8 week followup
|
|
Nervous system disorders
Dizziness
|
14.3%
12/84 • Number of events 12 • 28 Day treatment 8 week followup
|
3.3%
3/91 • Number of events 3 • 28 Day treatment 8 week followup
|
|
Psychiatric disorders
Insominia
|
8.3%
7/84 • Number of events 7 • 28 Day treatment 8 week followup
|
3.3%
3/91 • Number of events 3 • 28 Day treatment 8 week followup
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.0%
5/84 • Number of events 5 • 28 Day treatment 8 week followup
|
3.3%
3/91 • Number of events 3 • 28 Day treatment 8 week followup
|
|
Gastrointestinal disorders
Constipation
|
3.6%
3/84 • Number of events 3 • 28 Day treatment 8 week followup
|
3.3%
3/91 • Number of events 3 • 28 Day treatment 8 week followup
|
|
Gastrointestinal disorders
Diarrhea NOS
|
4.8%
4/84 • Number of events 4 • 28 Day treatment 8 week followup
|
4.4%
4/91 • Number of events 4 • 28 Day treatment 8 week followup
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
14/84 • Number of events 14 • 28 Day treatment 8 week followup
|
2.2%
2/91 • Number of events 2 • 28 Day treatment 8 week followup
|
|
Gastrointestinal disorders
Eructation
|
3.6%
3/84 • Number of events 3 • 28 Day treatment 8 week followup
|
0.00%
0/91 • 28 Day treatment 8 week followup
|
|
Gastrointestinal disorders
Flatulance
|
4.8%
4/84 • Number of events 4 • 28 Day treatment 8 week followup
|
1.1%
1/91 • Number of events 1 • 28 Day treatment 8 week followup
|
|
Gastrointestinal disorders
Nausea
|
20.2%
17/84 • Number of events 17 • 28 Day treatment 8 week followup
|
2.2%
2/91 • Number of events 2 • 28 Day treatment 8 week followup
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
5/84 • Number of events 5 • 28 Day treatment 8 week followup
|
1.1%
1/91 • Number of events 1 • 28 Day treatment 8 week followup
|
|
General disorders
Pyrexia
|
4.8%
4/84 • Number of events 4 • 28 Day treatment 8 week followup
|
0.00%
0/91 • 28 Day treatment 8 week followup
|
|
Investigations
Neutrophil decreased
|
7.1%
6/84 • Number of events 6 • 28 Day treatment 8 week followup
|
3.3%
3/91 • Number of events 3 • 28 Day treatment 8 week followup
|
|
Musculoskeletal and connective tissue disorders
back pain
|
7.1%
6/84 • Number of events 6 • 28 Day treatment 8 week followup
|
2.2%
2/91 • Number of events 2 • 28 Day treatment 8 week followup
|
|
Nervous system disorders
Headache
|
29.8%
25/84 • Number of events 25 • 28 Day treatment 8 week followup
|
18.7%
17/91 • Number of events 17 • 28 Day treatment 8 week followup
|
|
Nervous system disorders
Somnolence
|
3.6%
3/84 • Number of events 3 • 28 Day treatment 8 week followup
|
2.2%
2/91 • Number of events 2 • 28 Day treatment 8 week followup
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
4/84 • Number of events 4 • 28 Day treatment 8 week followup
|
1.1%
1/91 • Number of events 1 • 28 Day treatment 8 week followup
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place