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Trial record 34 of 332 for:    DONEPEZIL

Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease (SAVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02097056
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Intervention Drug: Donepezil HCL
Enrollment 171
Recruitment Details  
Pre-assignment Details Out of the 171 participants enrolled into the study, 1 was not treated resulting in 170 participants in the safety population.
Arm/Group Title Donepezil Hydrochloride
Hide Arm/Group Description Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
Period Title: Overall Study
Started 171
ParticipantsTreated 170
Completed 113
Not Completed 58
Reason Not Completed
Protocol Violation             2
Withdrawal by Subject             15
Lost to Follow-up             2
Adverse Event             37
Not specified             2
Arm/Group Title Donepezil Hydrochloride
Hide Arm/Group Description Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
Overall Number of Baseline Participants 170
Hide Baseline Analysis Population Description
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 170 participants
74.82  (7.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants
Female
123
  72.4%
Male
47
  27.6%
1.Primary Outcome
Title Overall Summary of Adverse Events (AEs)
Hide Description Safety of study drug was assessed by clinical laboratory assessments, vital signs, weight, 12-lead electrocardiogram (ECG), physical and neurological examination. Treatment-Emergent Adverse Events (TEAEs) were defined as any event not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Serious adverse events were defined as AEs that led to or were life-threatening, resulted in or prolonged hospitalization, caused important or long-lasting disability, caused congenital abnormality or malformation, or resulted in death. Adverse drug reactions were defined as any harmful or unintended reaction to study treatment and were considered possibly related or probably related to study drug. Specific AEs and SAEs due to changes in clinical laboratory assessments, vital signs, weight, ECG, and physical and neurological exam are listed in the safety section.
Time Frame Baseline (Day 1) up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment.
Arm/Group Title Donepezil Hydrochloride
Hide Arm/Group Description:
Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
Overall Number of Participants Analyzed 170
Measure Type: Number
Unit of Measure: Percentage of participants
AEs 67.65
ADRs 47.06
SAEs 7.06
Serious ADRs 0.59
2.Secondary Outcome
Title Change From Baseline in the Mini-Mental State Examination (MMSE) Score
Hide Description The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. The mean change was analyzed by Wilcoxon’s signed rank test.
Time Frame Baseline, Week 12, and Week 24 (Final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.
Arm/Group Title Donepezil Hydrochloride
Hide Arm/Group Description:
Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
Overall Number of Participants Analyzed 150
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Change W12 -0.31  (2.76)
Change W24 -0.40  (2.75)
3.Secondary Outcome
Title Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores
Hide Description The NPI-Q assessed twelve behavioral domains common in dementia including; hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep/night-time behavior change, and appetite/eating change. The questionnaire is given by the clinician to the patient’s caregiver who was asked if the behavior described is present in the patient. If “Yes”, the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale (1 = mild, 2= moderate, and 3= severe) and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme or very severe). The total severity score represents the sum of individual scores and ranges from 0 to 36. The total distress score represents the sum of individual symptom scores and ranges from 0 to 60.
Time Frame Baseline, Week 12, and Week 24 (Follow up visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.
Arm/Group Title Donepezil Hydrochloride
Hide Arm/Group Description:
Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
Overall Number of Participants Analyzed 150
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Change Week 12 (Severity) 0.33  (4.74)
Change Week 24 (Severity) 0.09  (5.67)
Change Week 12 (Distress) 0.19  (6.83)
Change Week 24 (Distress) 0.29  (7.60)
Time Frame AEs were collected from Day 1 through Week 24 of study.
Adverse Event Reporting Description Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
 
Arm/Group Title Donepezil Hydrochloride
Hide Arm/Group Description Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
All-Cause Mortality
Donepezil Hydrochloride
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Donepezil Hydrochloride
Affected / at Risk (%)
Total   12/170 (7.06%) 
Gastrointestinal disorders   
Diarrhoea  1  1/170 (0.59%) 
General disorders   
Gait disturbance  1  1/170 (0.59%) 
Infections and infestations   
Pneumonia  1  1/170 (0.59%) 
Injury, poisoning and procedural complications   
Femur fracture  1  2/170 (1.18%) 
Rib fracture  1  2/170 (1.18%) 
Ankle fracture  1  1/170 (0.59%) 
Cervical vertebral fracture  1  1/170 (0.59%) 
Ligament injury  1  1/170 (0.59%) 
Lumbar vertebral fracture  1  1/170 (0.59%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/170 (0.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Donepezil Hydrochloride
Affected / at Risk (%)
Total   109/170 (64.12%) 
Cardiac disorders   
Atrioventricular block second degree  1  2/170 (1.18%) 
Bradycardia  1  1/170 (0.59%) 
Eye disorders   
Eye pain  1  1/170 (0.59%) 
Gastrointestinal disorders   
Nausea  1  21/170 (12.35%) 
Vomiting  1  19/170 (11.18%) 
Diarrhoea  1  11/170 (6.47%) 
Dyspepsia  1  5/170 (2.94%) 
Abdominal discomfort  1  2/170 (1.18%) 
Gastrointestinal disorder  1  2/170 (1.18%) 
Abdominal pain  1  2/170 (1.18%) 
Faecal incontinence  1  2/170 (1.18%) 
Constipation  1  1/170 (0.59%) 
Dental caries  1  1/170 (0.59%) 
General disorders   
Asthenia  1  4/170 (2.35%) 
Fatigue  1  3/170 (1.76%) 
Gait disturbance  1  1/170 (0.59%) 
Chills  1  1/170 (0.59%) 
Oedema  1  1/170 (0.59%) 
Pain  1  1/170 (0.59%) 
Immune system disorders   
Hypersensitivity  1  1/170 (0.59%) 
Infections and infestations   
Nasopharyngitis  1  1/170 (0.59%) 
Periodontitis  1  1/170 (0.59%) 
Pharyngitis  1  1/170 (0.59%) 
Urinary tract infection  1  1/170 (0.59%) 
Injury, poisoning and procedural complications   
Ankle fracture  1  1/170 (0.59%) 
Contusion  1  2/170 (1.18%) 
Investigations   
Electrocardiogram QT prolonged  1  5/170 (2.94%) 
Weight decreased  1  5/170 (2.94%) 
Blood glucose increased  1  2/170 (1.18%) 
Glucose urine present  1  2/170 (1.18%) 
Alanine aminotransferase increased  1  1/170 (0.59%) 
Aspartate aminotransferase increased  1  1/170 (0.59%) 
Blood cholesterol increased  1  1/170 (0.59%) 
Blood creatine phosphokinase increased  1  1/170 (0.59%) 
Blood triglycerides increased  1  1/170 (0.59%) 
Electrocardiogram ST segment elevation  1  1/170 (0.59%) 
Electrocardiogram T wave abnormal  1  1/170 (0.59%) 
Metabolism and nutrition disorders   
Decreased appetite  1  16/170 (9.41%) 
Hyperlipidaemia  1  2/170 (1.18%) 
Hypophagia  1  2/170 (1.18%) 
Hyperglycaemia  1  1/170 (0.59%) 
Hypoglycaemia  1  1/170 (0.59%) 
Hyponatraemia  1  1/170 (0.59%) 
Nervous system disorders   
Dizziness  1  13/170 (7.65%) 
Lethargy  1  8/170 (4.71%) 
Headache  1  6/170 (3.53%) 
Somnolence  1  6/170 (3.53%) 
Sedation  1  2/170 (1.18%) 
Tremor  1  2/170 (1.18%) 
Dreamy state  1  1/170 (0.59%) 
Drooling  1  1/170 (0.59%) 
Dysarthria  1  1/170 (0.59%) 
Facial spasm  1  1/170 (0.59%) 
Hypersomnia  1  1/170 (0.59%) 
Paraesthesia  1  1/170 (0.59%) 
Psychiatric disorders   
Anxiety  1  6/170 (3.53%) 
Insomnia  1  5/170 (2.94%) 
Aggression  1  4/170 (2.35%) 
Behavioural and psychiatric symptoms of dementia  1  3/170 (1.76%) 
Depression  1  3/170 (1.76%) 
Irritability  1  2/170 (1.18%) 
Sleep disorder  1  2/170 (1.18%) 
Compulsions  1  1/170 (0.59%) 
Compulsive hoarding  1  1/170 (0.59%) 
Confusional state  1  1/170 (0.59%) 
Delusion  1  1/170 (0.59%) 
Depressed mood  1  1/170 (0.59%) 
Disinhibition  1  1/170 (0.59%) 
Nightmare  1  1/170 (0.59%) 
Restlessness  1  1/170 (0.59%) 
Renal and urinary disorders   
Urinary incontinence  1  6/170 (3.53%) 
Acute kidney injury  1  1/170 (0.59%) 
Enuresis  1  1/170 (0.59%) 
Incontinence  1  1/170 (0.59%) 
Nocturia  1  1/170 (0.59%) 
Pollakiuria  1  1/170 (0.59%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/170 (0.59%) 
Hiccups  1  1/170 (0.59%) 
Nasal discomfort  1  1/170 (0.59%) 
Productive cough  1  1/170 (0.59%) 
Rhinitis allergic  1  1/170 (0.59%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  2/170 (1.18%) 
Cold sweat  1  2/170 (1.18%) 
Vascular disorders   
Hypertension  1  2/170 (1.18%) 
Pallor  1  1/170 (0.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Youngji Pyo
Organization: Eisai Korea Inc.
Phone: +82-2-3451-5533
EMail: y-pyo@eisaikorea.com
Layout table for additonal information
Responsible Party: Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier: NCT02097056     History of Changes
Other Study ID Numbers: ART-M082-401
First Submitted: March 24, 2014
First Posted: March 26, 2014
Results First Submitted: March 30, 2016
Results First Posted: June 27, 2016
Last Update Posted: June 27, 2016