Trial Outcomes & Findings for The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease (NCT NCT01054976)
NCT ID: NCT01054976
Last Updated: 2012-12-24
Results Overview
The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time when the color of the computer screen changes from black to white by performing a total of 70 times for six minutes.
COMPLETED
PHASE4
99 participants
Baseline, Week 12
2012-12-24
Participant Flow
Of the total of 99 enrolled patients, only 92 were screened.
Participant milestones
| Measure |
Galantamine
8 mg/day for 4 weeks; 16 mg/day thereafter
|
|---|---|
|
Overall Study
STARTED
|
92
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Galantamine
8 mg/day for 4 weeks; 16 mg/day thereafter
|
|---|---|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Uncooperative participations to study
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Other
|
8
|
Baseline Characteristics
The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Galantamine
n=92 Participants
8 mg/day for 4 weeks; 16 mg/day thereafter
|
|---|---|
|
Age Continuous
|
73.24 Years
STANDARD_DEVIATION 7.969 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Per-protocol (PP) analysis set.
The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time when the color of the computer screen changes from black to white by performing a total of 70 times for six minutes.
Outcome measures
| Measure |
Galantamine
n=92 Participants
8 mg/day for 4 weeks; 16 mg/day thereafter
|
|---|---|
|
Change From Baseline in Simple Reaction Time
Week 4 (n=83)
|
-30.92 seconds
Standard Deviation 1277.0
|
|
Change From Baseline in Simple Reaction Time
Week 12 (n=73)
|
180.83 seconds
Standard Deviation 519.18
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Per-protocol (PP) analysis set.
The Choice Reaction Time is a computerized attention test that evaluates the reaction time and the number of errors by showing patients one card on the computer screen and making them find the same one among similar four cards. The test is performed a total of 12 times.
Outcome measures
| Measure |
Galantamine
n=92 Participants
8 mg/day for 4 weeks; 16 mg/day thereafter
|
|---|---|
|
Change From Baseline in Choice Reaction Time
Week 4 (n=80)
|
429.54 seconds
Standard Deviation 3388.0
|
|
Change From Baseline in Choice Reaction Time
Week 12 (n=73)
|
1331 seconds
Standard Deviation 3627.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intention-to-Treat analysis set.
The Alzheimer's disease Assessment Scale-Cognitive subscale (ADAS-Cog) is an instrument used to assess cognitive dysfunction in individuals with Alzheimer disease and other dementias. It consists of 11 items, with scores ranging from 1 to 70. Maximum score is 70. Higher scores indicate worsening.
Outcome measures
| Measure |
Galantamine
n=73 Participants
8 mg/day for 4 weeks; 16 mg/day thereafter
|
|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
|
1.31 scores on a scale
Standard Deviation 5.67
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intention-to-Treat analysis set.
DAD-K is the Korean version of the Assessment for Dementia Scale, a tool developed to evaluate the Alzheimer patients' function including both basic and instrumental Activities of Daily Livings (ADL). It evaluates one function from various perspectives including behavior initiation, plan and preparation, and valid performance. It consists of 10 questions, each can score either 0 (no) or 1 (yes), if not applicable, patient will check on "not applicable (x)" which will not count in the calculation. Scores range from 0 to 100. Higher score represents better function
Outcome measures
| Measure |
Galantamine
n=73 Participants
8 mg/day for 4 weeks; 16 mg/day thereafter
|
|---|---|
|
Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K)
|
-1.41 scores on a scale
Standard Deviation 10.53
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intention-to-Treat analysis set.
The Seoul-Instrumental Activities of Daily Living (S-IADL) assesses patients' abilities to perform instrumental and social activities of daily living. These include the ability to prepare a balanced meal, remember appointments, keep financial records, remember to take medication, and so on. It is composed of 15 items, with scores ranging from 0 to 45. Lower scores indicate better functioning.
Outcome measures
| Measure |
Galantamine
n=73 Participants
8 mg/day for 4 weeks; 16 mg/day thereafter
|
|---|---|
|
Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL)
|
1.22 scores on a scale
Standard Deviation 6.88
|
Adverse Events
Galantamine
Serious adverse events
| Measure |
Galantamine
n=92 participants at risk
8 mg/day for 4 weeks; 16 mg/day thereafter
|
|---|---|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
2/92 • 12 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
2.2%
2/92 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Asthenia
|
1.1%
1/92 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/92 • 12 weeks
|
|
General disorders
Headache
|
1.1%
1/92 • 12 weeks
|
|
Psychiatric disorders
Delirium
|
1.1%
1/92 • 12 weeks
|
|
Nervous system disorders
Brain stem infarction
|
1.1%
1/92 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.1%
1/92 • 12 weeks
|
|
Nervous system disorders
Neuromyopathy
|
1.1%
1/92 • 12 weeks
|
Other adverse events
| Measure |
Galantamine
n=92 participants at risk
8 mg/day for 4 weeks; 16 mg/day thereafter
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
16.3%
15/92 • 12 weeks
|
|
Nervous system disorders
Dizziness/vertigo
|
7.6%
7/92 • 12 weeks
|
|
Nervous system disorders
Anorexia
|
6.5%
6/92 • 12 weeks
|
|
General disorders
Headache
|
5.4%
5/92 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
5/92 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
4/92 • 12 weeks
|
|
Cardiac disorders
Chest discomfort
|
2.2%
2/92 • 12 weeks
|
|
Metabolism and nutrition disorders
Weight loss
|
2.2%
2/92 • 12 weeks
|
|
General disorders
Insomnia
|
2.2%
2/92 • 12 weeks
|
|
Metabolism and nutrition disorders
Poor appetite
|
2.2%
2/92 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Asthenia
|
2.2%
2/92 • 12 weeks
|
|
General disorders
Cold
|
2.2%
2/92 • 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
2/92 • 12 weeks
|
|
General disorders
Lethargy
|
2.2%
2/92 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.2%
2/92 • 12 weeks
|
|
General disorders
Fall
|
1.1%
1/92 • 12 weeks
|
|
General disorders
Fatigue
|
1.1%
1/92 • 12 weeks
|
|
Gastrointestinal disorders
Belching
|
1.1%
1/92 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/92 • 12 weeks
|
|
General disorders
Sleep disorder
|
1.1%
1/92 • 12 weeks
|
|
Psychiatric disorders
Depression
|
1.1%
1/92 • 12 weeks
|
|
Psychiatric disorders
Dementia
|
1.1%
1/92 • 12 weeks
|
|
General disorders
Sun stroke
|
1.1%
1/92 • 12 weeks
|
|
Nervous system disorders
Tonic pain
|
1.1%
1/92 • 12 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
1.1%
1/92 • 12 weeks
|
|
Ear and labyrinth disorders
Hearing loss
|
1.1%
1/92 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/92 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Rigor
|
1.1%
1/92 • 12 weeks
|
|
General disorders
Sweating
|
1.1%
1/92 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
1.1%
1/92 • 12 weeks
|
|
General disorders
Somnolence
|
1.1%
1/92 • 12 weeks
|
|
Psychiatric disorders
Confusion
|
1.1%
1/92 • 12 weeks
|
|
Gastrointestinal disorders
Intermittent indigestion
|
1.1%
1/92 • 12 weeks
|
|
Nervous system disorders
Tremor
|
1.1%
1/92 • 12 weeks
|
Additional Information
Business Unit Director
Jan-Cil Korea
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release (time limit not indicated).
- Publication restrictions are in place
Restriction type: OTHER