Trial Outcomes & Findings for Galantamine and Memantine Combination for Cognitive Impairments in Schizophrenia (NCT NCT02234752)
NCT ID: NCT02234752
Last Updated: 2017-11-09
Results Overview
The primary outcome measure will be the change in level of cognition as measured by the MATRICS Consensus Cognitive Battery (MCCB). In schizophrenia, usual composite scores are 20-39. In healthy controls, usual composite scores are normalized to 40-60. Higher values of composite scores mean better cognition. Test scores are normalized to healthy controls, therefore no min-max range is available. Final scores calculated by MATRICS Consensus Cognitive Battery software. Exact minimum/maximum are not known to provider. Overall composite scores are reported.
TERMINATED
PHASE2
3 participants
Baseline and 6-Weeks
2017-11-09
Participant Flow
Participant milestones
| Measure |
Galantamine ER, Memantine XR
Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Galantamine ER
Memantine XR
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Galantamine and Memantine Combination for Cognitive Impairments in Schizophrenia
Baseline characteristics by cohort
| Measure |
Galantamine ER, Memantine XR
n=3 Participants
Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Galantamine ER
Memantine XR
|
|---|---|
|
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
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6-WeeksPopulation: Participant 3 only provided baseline data
The primary outcome measure will be the change in level of cognition as measured by the MATRICS Consensus Cognitive Battery (MCCB). In schizophrenia, usual composite scores are 20-39. In healthy controls, usual composite scores are normalized to 40-60. Higher values of composite scores mean better cognition. Test scores are normalized to healthy controls, therefore no min-max range is available. Final scores calculated by MATRICS Consensus Cognitive Battery software. Exact minimum/maximum are not known to provider. Overall composite scores are reported.
Outcome measures
| Measure |
Galantamine ER, Memantine XR
n=3 Participants
Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Galantamine ER
Memantine XR
|
|---|---|
|
Change in Level of Cognition
Baseline Participant 1
|
48 units on a scale
|
|
Change in Level of Cognition
Week 6 Participant 1
|
48 units on a scale
|
|
Change in Level of Cognition
Baseline Participant 2
|
32 units on a scale
|
|
Change in Level of Cognition
Week 6 Participant 2
|
25 units on a scale
|
|
Change in Level of Cognition
Baseline Participant 3
|
9 units on a scale
|
SECONDARY outcome
Timeframe: Baseline and 6-WeeksPopulation: Participant 3 only provided baseline data
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.
Outcome measures
| Measure |
Galantamine ER, Memantine XR
n=3 Participants
Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Galantamine ER
Memantine XR
|
|---|---|
|
Free Tryptophan (TRP)
Baseline tryptophan Participant 1
|
51.94 µM
Standard Deviation 2.39
|
|
Free Tryptophan (TRP)
Week-6 tryptophan Participant 1
|
55.72 µM
Standard Deviation 2.83
|
|
Free Tryptophan (TRP)
Baseline tryptophan Participant 2
|
32.17 µM
Standard Deviation 1.05
|
|
Free Tryptophan (TRP)
Week-6 tryptophan Participant 2
|
24.96 µM
Standard Deviation 1.33
|
|
Free Tryptophan (TRP)
Baseline tryptophan Participant 3
|
35.07 µM
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline and 6-WeeksPopulation: Participant 3 only provided baseline data
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. MS\* AUC is mass spectrometry times area under the curve.
Outcome measures
| Measure |
Galantamine ER, Memantine XR
n=3 Participants
Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Galantamine ER
Memantine XR
|
|---|---|
|
Kynurenic Acid (KYNA)
Baseline KYNA Participant 1
|
103911 MS* AUC
Standard Deviation 20870
|
|
Kynurenic Acid (KYNA)
Week-6 KYNA Participant 1
|
83737 MS* AUC
Standard Deviation 25309
|
|
Kynurenic Acid (KYNA)
Baseline KYNA Participant 2
|
95139 MS* AUC
Standard Deviation 36663
|
|
Kynurenic Acid (KYNA)
Week-6 KYNA Participant 2
|
73280 MS* AUC
Standard Deviation 15567
|
|
Kynurenic Acid (KYNA)
Baseline KYNA Participant 3
|
93163 MS* AUC
Standard Deviation 41519
|
SECONDARY outcome
Timeframe: Baseline and 6-WeeksPopulation: Participant 3 only provided baseline data
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.
Outcome measures
| Measure |
Galantamine ER, Memantine XR
n=3 Participants
Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Galantamine ER
Memantine XR
|
|---|---|
|
Kynurenine (KYN)
Baseline KYN Participant 1
|
1.62 µM
Standard Deviation 0.12
|
|
Kynurenine (KYN)
Week-6 KYN Participant 1
|
1.85 µM
Standard Deviation 0.24
|
|
Kynurenine (KYN)
Baseline KYN Participant 2
|
0.86 µM
Standard Deviation 0.13
|
|
Kynurenine (KYN)
Week-6 KYN Participant 2
|
0.71 µM
Standard Deviation 0.05
|
|
Kynurenine (KYN)
Baseline KYN Participant 3
|
0.76 µM
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Baseline and 6-WeeksPopulation: Participant 3 only provided baseline data
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. MS\* AUC is mass spectrometry times area under the curve.
Outcome measures
| Measure |
Galantamine ER, Memantine XR
n=3 Participants
Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Galantamine ER
Memantine XR
|
|---|---|
|
Picolinic Acid (PIC)
Baseline PIC Participant 1
|
44021 MS* AUC
Standard Deviation 4470
|
|
Picolinic Acid (PIC)
Week-6 PIC Participant 1
|
29542 MS* AUC
Standard Deviation 383
|
|
Picolinic Acid (PIC)
Baseline PIC Participant 2
|
81883 MS* AUC
Standard Deviation 7344
|
|
Picolinic Acid (PIC)
Week-6 PIC Participant 2
|
63745 MS* AUC
Standard Deviation 1535
|
|
Picolinic Acid (PIC)
Baseline PIC Participant 3
|
40189 MS* AUC
Standard Deviation 4342
|
SECONDARY outcome
Timeframe: Baseline and 6-WeeksPopulation: Participant 3 only provided baseline data
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.
Outcome measures
| Measure |
Galantamine ER, Memantine XR
n=3 Participants
Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Galantamine ER
Memantine XR
|
|---|---|
|
KYN/TRP
Baseline KYN/TRP Participant 1
|
1.21 AUC Ratio
|
|
KYN/TRP
Week-6 KYN/TRP Participant 1
|
1.31 AUC Ratio
|
|
KYN/TRP
Baseline KYN/TRP Participant 2
|
1.06 AUC Ratio
|
|
KYN/TRP
Week-6 KYN/TRP Participant 2
|
0.8 AUC Ratio
|
|
KYN/TRP
Baseline KYN/TRP Participant 3
|
0.79 AUC Ratio
|
SECONDARY outcome
Timeframe: Baseline and 6-WeeksPopulation: Participant 3 only provided baseline data
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.
Outcome measures
| Measure |
Galantamine ER, Memantine XR
n=3 Participants
Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Galantamine ER
Memantine XR
|
|---|---|
|
KYNA/KYN
Baseline KYNA/KYN Participant 2
|
0.121 AUC Ratio
|
|
KYNA/KYN
Baseline KYNA/KYN Participant 1
|
0.075 AUC Ratio
|
|
KYNA/KYN
Week-6 KYNA/KYN Participant 1
|
0.050 AUC Ratio
|
|
KYNA/KYN
Week-6 KYNA/KYN Participant 2
|
0.114 AUC Ratio
|
|
KYNA/KYN
Baseline KYNA/KYN Participant 3
|
0.152 AUC Ratio
|
SECONDARY outcome
Timeframe: Baseline and 6-WeeksPopulation: Participant 3 only provided baseline data
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.
Outcome measures
| Measure |
Galantamine ER, Memantine XR
n=3 Participants
Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Galantamine ER
Memantine XR
|
|---|---|
|
PIC/KYN
Baseline PIC/KYN Participant 1
|
0.0317 AUC Ratio
|
|
PIC/KYN
Week-6 PIC/KYN Participant 1
|
0.0175 AUC Ratio
|
|
PIC/KYN
Baseline PIC/KYN Participant 2
|
0.1039 AUC Ratio
|
|
PIC/KYN
Week-6 PIC/KYN Participant 2
|
0.0989 AUC Ratio
|
|
PIC/KYN
Baseline PIC/KYN Participant 3
|
0.0655 AUC Ratio
|
Adverse Events
Galantamine ER, Memantine XR
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Galantamine ER, Memantine XR
n=3 participants at risk
Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Galantamine ER
Memantine XR
|
|---|---|
|
General disorders
Increased tiredness
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Lightheadedness
|
33.3%
1/3 • Number of events 3
|
|
General disorders
Dizziness
|
33.3%
1/3 • Number of events 1
|
Additional Information
Maju Koola
George Washington University, Washington, DC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place