Trial Outcomes & Findings for Efficacy Study of Galantamine for Cognitive Impairments in Schizophrenia (NCT NCT00176423)

Results Overview

Participants were administered an eight-test neuropsychological test battery at baseline and end-of-study. The battery included the following tests: working memory: WAIS-III Letter-Number Sequencing and Brief Assessment of Cognition in Schizophrenia Number Sequencing; verbal memory: California Verbal Learning Test (CVLT); visual memory: Brief Visuospatial Memory Test (BVMT); motor speed: Grooved Pegboard; processing speed: WAIS-III Digit Symbol and WAIS-III Symbol Search; and the Gordon Diagnostic System CPT. Alternate forms of the CVLT and BVMT were used for the two test occasions. For each neuropsychological test, participant scores were converted to z-scores: z = (score - baseline mean)/baseline SD. For the primary outcome measure, an overall composite z-score was computed from the average of the individual test z-scores. A positive z-score would reflect better performance compared to baseline; a negative z-score would reflect worse performance compared to baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

117 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-12-16

Participant Flow

The number of people who signed informed consent was "117". Thirty-one participants who signed informed consent did not complete the Evaluation Phase of the study and were not randomized. Eight-six (86) participants completed the Evaluation Phase of the study and were randomized.

Participant milestones

Participant milestones
Measure	Galantamine galantamine, 24mgs, p.o., qday	Placebo placebo, 3 tablets, p.o., qday
Overall Study STARTED	42	44
Overall Study COMPLETED	35	38
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of Galantamine for Cognitive Impairments in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Galantamine n=42 Participants galantamine, 24mgs, p.o., qday galantamine: see arm/group description	Placebo n=44 Participants placebo, 3 tablets, p.o., qday galantamine: see arm/group description	Total n=86 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	42 Participants n=5 Participants	44 Participants n=7 Participants	86 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	44 participants n=7 Participants	86 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Participants were administered an eight-test neuropsychological test battery at baseline and end-of-study. The battery included the following tests: working memory: WAIS-III Letter-Number Sequencing and Brief Assessment of Cognition in Schizophrenia Number Sequencing; verbal memory: California Verbal Learning Test (CVLT); visual memory: Brief Visuospatial Memory Test (BVMT); motor speed: Grooved Pegboard; processing speed: WAIS-III Digit Symbol and WAIS-III Symbol Search; and the Gordon Diagnostic System CPT. Alternate forms of the CVLT and BVMT were used for the two test occasions. For each neuropsychological test, participant scores were converted to z-scores: z = (score - baseline mean)/baseline SD. For the primary outcome measure, an overall composite z-score was computed from the average of the individual test z-scores. A positive z-score would reflect better performance compared to baseline; a negative z-score would reflect worse performance compared to baseline.

Outcome measures

Outcome measures
Measure	Galantamine n=35 Participants galantamine, 24mgs, p.o., qday galantamine: see arm/group description	Placebo n=38 Participants placebo, 3 tablets, p.o., qday galantamine: see arm/group description
Overall Cognitive Improvement Z-score Week 0	0.03 z-score Standard Deviation 0.64	-0.03 z-score Standard Deviation 0.05
Overall Cognitive Improvement Z-score Week 12	0.15 z-score Standard Deviation 0.68	0.61 z-score Standard Deviation 0.55

SECONDARY outcome

Timeframe: 12 weeks

Three measures were examined: PR interval, QRS interval, and QTc interval. The three measures were derived from a standard 12-lead ECG recording.

Outcome measures

Outcome measures
Measure	Galantamine n=42 Participants galantamine, 24mgs, p.o., qday galantamine: see arm/group description	Placebo n=44 Participants placebo, 3 tablets, p.o., qday galantamine: see arm/group description
ECG Changes From Baseline to 12 Weeks. PR interval	25.7 msec Standard Deviation 56.0	3.0 msec Standard Deviation 12.0
ECG Changes From Baseline to 12 Weeks. QRS interval	11.4 msec Standard Deviation 25.1	-1.6 msec Standard Deviation 11.7
ECG Changes From Baseline to 12 Weeks. QTc interval	3.03 msec Standard Deviation 28.89	3.03 msec Standard Deviation 27.68

SECONDARY outcome

Timeframe: 12 weeks (Week 12 - Week 0)

The SAS total were calculated by adding scores from scales #1-#11. Each scale ranges from "0=None/Normal" to "4=Extreme/Severe". The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating.

Outcome measures

Outcome measures
Measure	Galantamine n=42 Participants galantamine, 24mgs, p.o., qday galantamine: see arm/group description	Placebo n=44 Participants placebo, 3 tablets, p.o., qday galantamine: see arm/group description
Simpson Angus Scale (SAS) Total Score Week 0	1.4 score on a scale Standard Deviation 1.8	1.6 score on a scale Standard Deviation 2.1
Simpson Angus Scale (SAS) Total Score Week 12	1.1 score on a scale Standard Deviation 1.8	1.6 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 12 weeks (Week 12 - Week 0)

Change in AIMS Total Score: Frequencies of Maximum Within-Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from "0=None" to "4=Severe". The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating.

Outcome measures

Outcome measures
Measure	Galantamine n=42 Participants galantamine, 24mgs, p.o., qday galantamine: see arm/group description	Placebo n=44 Participants placebo, 3 tablets, p.o., qday galantamine: see arm/group description
Abnormal Involuntary Movement Scale (AIMS) Week 12	2.1 score on a scale Standard Deviation 3.0	1.6 score on a scale Standard Deviation 3.0
Abnormal Involuntary Movement Scale (AIMS) Week 0	2.0 score on a scale Standard Deviation 3.1	2.1 score on a scale Standard Deviation 3.1

Adverse Events

Galantamine

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Galantamine n=42 participants at risk galantamine, 24mgs, p.o., qday galantamine: see arm/group description	Placebo n=44 participants at risk placebo, 3 tablets, p.o., qday galantamine: see arm/group description
Respiratory, thoracic and mediastinal disorders hospitalization due to pneumonia	2.4% 1/42	0.00% 0/44

Other adverse events

Other adverse events
Measure	Galantamine n=42 participants at risk galantamine, 24mgs, p.o., qday galantamine: see arm/group description	Placebo n=44 participants at risk placebo, 3 tablets, p.o., qday galantamine: see arm/group description
Psychiatric disorders worsening of psychiatric symptoms	2.4% 1/42	2.3% 1/44
Social circumstances increased alcohol consumption	2.4% 1/42	0.00% 0/44
Ear and labyrinth disorders dizziness	0.00% 0/42	2.3% 1/44

Additional Information

Robert W. Buchanan, M.D.

Maryland Psychiatric Research Center

Phone: 410-402-7876

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place