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Trial record 98 of 331 for:    DONEPEZIL

Open-Label Extension Study of 23 mg Donepezil SR in Patients With Moderate to Severe Alzheimer's Disease

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: NCT00566501
Recruitment Status : Completed
First Posted : December 3, 2007
Results First Posted : June 19, 2012
Last Update Posted : July 11, 2014
Sponsor:
Collaborator:
Eisai Limited
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: 23 mg SR in Study 326
Drug: 10 mg IR in Study 326
Enrollment 915
Recruitment Details This study was recruited at 179 centers in Asia, Europe, North America, Oceania, South Africa, and South America during the period of 14 December 2007 to 01 April 2010.
Pre-assignment Details This study (E2020-G000-328) was a 12-month, open-label extension of study E2020-G000-326. Subjects who had received donepezil 10 mg IR or donepezil 23 mg IR during Study 326 were eligible for enrollment into this study.
Arm/Group Title 23 mg SR in Study 326 10 mg IR in Study 326
Hide Arm/Group Description Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study. Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
Period Title: Overall Study
Started 579 336
Safety Population 570 332
Discontinued 146 122
Adverse Event 68 59
Lack of Efficacy 8 3
Withdraw of Consent by Subject 33 30
Request of Investigator or Sponsor 6 7
Protocol Violation 2 2
Medication Non-compliance 5 0
Other ( Not Specified) 24 21
Not Determined 1 0
Completed 423 210
Not Completed 156 126
Arm/Group Title 23 mg SR in Study 326 10 mg IR in Study 326 Total
Hide Arm/Group Description Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study. Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study. Total of all reporting groups
Overall Number of Baseline Participants 579 336 915
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 579 participants 336 participants 915 participants
74.1  (8.63) 74.5  (8.46) 74.2  (8.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 579 participants 336 participants 915 participants
Female
378
  65.3%
204
  60.7%
582
  63.6%
Male
201
  34.7%
132
  39.3%
333
  36.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 579 participants 336 participants 915 participants
American Indian or Alaska Native 0 0 0
Asian 82 62 144
Black or African American 17 7 24
White 435 246 681
Other ( not specified) 3 2 5
Hispanic 42 19 61
1.Primary Outcome
Title Long-term Safety as Measured by Incidence of Adverse Events During the 12 Month Treatment Period
Hide Description Adverse events (AEs), including SAEs, were recorded from the time of consent. Recording of AEs ceased after the Final Visit or Early Termination Visit, except that SAEs were monitored for 30 days after study drug discontinuation.
Time Frame Throughout the study ( 12 months for all AEs and up to an additional 30 days for SAEs)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all subjects who received at least one dose of donepezil SR 23 mg during Study 328. Two groups were categorized: those who received donepezil 10 mg IR and those who received donepezil 23 mg SR during Study 326.
Arm/Group Title 23 mg SR in Study 326 10 mg IR in Study 326
Hide Arm/Group Description:
Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
Overall Number of Participants Analyzed 570 332
Measure Type: Number
Unit of Measure: participants
570 332
2.Secondary Outcome
Title Mean Change From Baseline in MMSE Score
Hide Description The Mini-Mental State Examination (MMSE) is a brief, 30-item test of cognitive function.
Time Frame 12 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Mean Change From Baseline in SIB Score
Hide Description The Severe Impairment Battery (SIB) evaluates the severity of cognitive dysfunction in patients with more advanced dementia.
Time Frame 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 23 mg SR in Study 326 10 mg IR in Study 326
Hide Arm/Group Description Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study. Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
All-Cause Mortality
23 mg SR in Study 326 10 mg IR in Study 326
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
23 mg SR in Study 326 10 mg IR in Study 326
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/570 (14.04%)      56/332 (16.87%)    
Blood and lymphatic system disorders     
Anemia  1/570 (0.18%)  0/332 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  0/570 (0.00%)  1/332 (0.30%) 
Angina pectoris  1/570 (0.18%)  0/332 (0.00%) 
Arrhythmia supraventricular  0/570 (0.00%)  1/332 (0.30%) 
Atrial fibrillation  0/570 (0.00%)  2/332 (0.60%) 
Bradycardia  2/570 (0.35%)  0/332 (0.00%) 
Cardiac failure  1/570 (0.18%)  1/332 (0.30%) 
Myocardial infarction  2/570 (0.35%)  0/332 (0.00%) 
Ventricular tachycardia  1/570 (0.18%)  0/332 (0.00%) 
Cardio-respiratory arrest  1/570 (0.18%)  1/332 (0.30%) 
Cardio-rspiratory arrest  1/570 (0.18%)  0/332 (0.00%) 
Congenital, familial and genetic disorders     
Encephalocele  0/570 (0.00%)  1/332 (0.30%) 
Hydrocele  1/570 (0.18%)  0/332 (0.00%) 
Meningocele  0/570 (0.00%)  1/332 (0.30%) 
Gastrointestinal disorders     
Abdominal pain  0/570 (0.00%)  1/332 (0.30%) 
Diarrhoea  1/570 (0.18%)  1/332 (0.30%) 
Duodenal ulcer  1/570 (0.18%)  0/332 (0.00%) 
Gastric ulcer  0/570 (0.00%)  1/332 (0.30%) 
Gastrointestinal hemorrhage  1/570 (0.18%)  0/332 (0.00%) 
Haematemesis  0/570 (0.00%)  2/332 (0.60%) 
Haematochezia  1/570 (0.18%)  0/332 (0.00%) 
Ileus paralytic  1/570 (0.18%)  0/332 (0.00%) 
Oesophageal ulcer  1/570 (0.18%)  0/332 (0.00%) 
Pancreatic mass  1/570 (0.18%)  0/332 (0.00%) 
Upper gastrointestinal hemorrhage  1/570 (0.18%)  0/332 (0.00%) 
vomiting  0/570 (0.00%)  1/332 (0.30%) 
General disorders     
Asthenia  1/570 (0.18%)  0/332 (0.00%) 
Chest pain  1/570 (0.18%)  0/332 (0.00%) 
Death  2/570 (0.35%)  0/332 (0.00%) 
Gait disturbance  1/570 (0.18%)  0/332 (0.00%) 
Multi-organ failure  0/570 (0.00%)  1/332 (0.30%) 
Non-cardiac chest pain  1/570 (0.18%)  0/332 (0.00%) 
Sudden death  0/570 (0.00%)  1/332 (0.30%) 
Hepatobiliary disorders     
Cholecystitis acute  0/570 (0.00%)  1/332 (0.30%) 
Hepatic cirrhosis  0/570 (0.00%)  1/332 (0.30%) 
Infections and infestations     
Abdominal abscess  1/570 (0.18%)  0/332 (0.00%) 
Bronchitis  0/570 (0.00%)  1/332 (0.30%) 
Cellulitis staphylococcal  1/570 (0.18%)  0/332 (0.00%) 
Gastroenteritis  2/570 (0.35%)  0/332 (0.00%) 
Liver abscess  0/570 (0.00%)  1/332 (0.30%) 
Lobar pneumonia  0/570 (0.00%)  1/332 (0.30%) 
Lower respiratory tract infection  2/570 (0.35%)  0/332 (0.00%) 
Orchitis  1/570 (0.18%)  0/332 (0.00%) 
Peritonillar abscess  1/570 (0.18%)  0/332 (0.00%) 
pneumonia  6/570 (1.05%)  1/332 (0.30%) 
Respiratory tract infection  0/570 (0.00%)  1/332 (0.30%) 
Sepsis  1/570 (0.18%)  0/332 (0.00%) 
Tuberculosis  1/570 (0.18%)  0/332 (0.00%) 
Urinary tract infection  8/570 (1.40%)  3/332 (0.90%) 
Injury, poisoning and procedural complications     
Concussion  1/570 (0.18%)  0/332 (0.00%) 
Device lead damage  1/570 (0.18%)  0/332 (0.00%) 
Dislocation of joint prosthesis  0/570 (0.00%)  1/332 (0.30%) 
Fall  7/570 (1.23%)  2/332 (0.60%) 
Femoral neck fracture  3/570 (0.53%)  0/332 (0.00%) 
Femur fracture  2/570 (0.35%)  0/332 (0.00%) 
Head injury  1/570 (0.18%)  0/332 (0.00%) 
Hip fracture  2/570 (0.35%)  1/332 (0.30%) 
Laceration  1/570 (0.18%)  1/332 (0.30%) 
Lumbar vertebral fracture  1/570 (0.18%)  0/332 (0.00%) 
Radius fracture  0/570 (0.00%)  1/332 (0.30%) 
Road traffic accident  1/570 (0.18%)  0/332 (0.00%) 
Skin laceration  1/570 (0.18%)  0/332 (0.00%) 
Subdural haematoma  1/570 (0.18%)  3/332 (0.90%) 
Thoracic vertebral fracture  1/570 (0.18%)  0/332 (0.00%) 
Upper limb fracture  1/570 (0.18%)  1/332 (0.30%) 
Subdural haemorrhage  1/570 (0.18%)  0/332 (0.00%) 
Investigations     
Electrocardiogram QT prolonged  1/570 (0.18%)  0/332 (0.00%) 
Lipase increased  0/570 (0.00%)  1/332 (0.30%) 
Weight decreased  1/570 (0.18%)  0/332 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  0/570 (0.00%)  1/332 (0.30%) 
Dehydration  2/570 (0.35%)  3/332 (0.90%) 
Gout  0/570 (0.00%)  1/332 (0.30%) 
Hypokalaemia  1/570 (0.18%)  0/332 (0.00%) 
Hyponatremia  0/570 (0.00%)  2/332 (0.60%) 
Musculoskeletal and connective tissue disorders     
Muscle rigidity  0/570 (0.00%)  1/332 (0.30%) 
Osteoarthritis  1/570 (0.18%)  0/332 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1/570 (0.18%)  0/332 (0.00%) 
Lung carcinoma cell type unspecified stage IV  1/570 (0.18%)  0/332 (0.00%) 
Lung neoplasm  1/570 (0.18%)  1/332 (0.30%) 
Malignant melanoma  0/570 (0.00%)  1/332 (0.30%) 
Metastases to liver  1/570 (0.18%)  0/332 (0.00%) 
Metastases to spine  0/570 (0.00%)  1/332 (0.30%) 
Metastasis  1/570 (0.18%)  0/332 (0.00%) 
Prostate cancer  0/570 (0.00%)  2/332 (0.60%) 
Prostate cancer stage II  0/570 (0.00%)  1/332 (0.30%) 
Rectal cancer  1/570 (0.18%)  0/332 (0.00%) 
Lung neoplasm malignant  1/570 (0.18%)  1/332 (0.30%) 
Nervous system disorders     
Bradykinesia  0/570 (0.00%)  1/332 (0.30%) 
Cerebral atrophy  1/570 (0.18%)  0/332 (0.00%) 
Cerebral hemorrhage  1/570 (0.18%)  1/332 (0.30%) 
Cerebral infarction  0/570 (0.00%)  1/332 (0.30%) 
Cerebrospinal fistula  0/570 (0.00%)  1/332 (0.30%) 
Cerebrovascular accident  5/570 (0.88%)  2/332 (0.60%) 
Convulsion  1/570 (0.18%)  0/332 (0.00%) 
Dementia Alzheimers type  2/570 (0.35%)  570 0/332 (0.00%) 
Dizziness  1/570 (0.18%)  1/332 (0.30%) 
Encephalopathy  1/570 (0.18%)  0/332 (0.00%) 
Epilepsy  0/570 (0.00%)  1/332 (0.30%) 
Headache  0/570 (0.00%)  1/332 (0.30%) 
Hemiparesis  1/570 (0.18%)  0/332 (0.00%) 
Hemiplegia  0/570 (0.00%)  1/332 (0.30%) 
Hydrocephalus  1/570 (0.18%)  0/332 (0.00%) 
Ischemic cerebral infarction  0/570 (0.00%)  1/332 (0.30%) 
Lacunar infarction  0/570 (0.00%)  1/332 (0.30%) 
Presyncope  1/570 (0.18%)  0/332 (0.00%) 
Sciatica  1/570 (0.18%)  0/332 (0.00%) 
Status epilepticus  0/570 (0.00%)  1/332 (0.30%) 
Syncope  6/570 (1.05%)  6/332 (1.81%) 
Transient ischemic attack  1/570 (0.18%)  3/332 (0.90%) 
Unresponsive to stimuli  1/570 (0.18%)  0/332 (0.00%) 
Psychiatric disorders     
Aggression  1/570 (0.18%)  3/332 (0.90%) 
Agitation  0/570 (0.00%)  2/332 (0.60%) 
Anxiety  0/570 (0.00%)  1/332 (0.30%) 
Hallucination  0/570 (0.00%)  1/332 (0.30%) 
Insomnia  0/570 (0.00%)  3/332 (0.90%) 
Mental status change  0/570 (0.00%)  4/332 (1.20%) 
Poriomania  1/570 (0.18%)  0/332 (0.00%) 
Psychotic disorder  0/570 (0.00%)  1/332 (0.30%) 
Restlessness  1/570 (0.18%)  2/332 (0.60%) 
Renal and urinary disorders     
Calculus bladder  1/570 (0.18%)  0/332 (0.00%) 
Haematuria  1/570 (0.18%)  1/332 (0.30%) 
Nephrolithiasis  1/570 (0.18%)  0/332 (0.00%) 
Neurogenic bladder  0/570 (0.00%)  1/332 (0.30%) 
Renal failure  1/570 (0.18%)  0/332 (0.00%) 
Urinary retention  1/570 (0.18%)  0/332 (0.00%) 
Renal failure acute  1/570 (0.18%)  2/332 (0.60%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  2/570 (0.35%)  0/332 (0.00%) 
Prostatomegaly  1/570 (0.18%)  0/332 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Choking  1/570 (0.18%)  0/332 (0.00%) 
Chronic obstructive pulmonary disease  1/570 (0.18%)  1/332 (0.30%) 
Dyspnea  3/570 (0.53%)  0/332 (0.00%) 
Lung disorder  1/570 (0.18%)  0/332 (0.00%) 
Pleural effusion  1/570 (0.18%)  0/332 (0.00%) 
Pulmonary embolism  0/570 (0.00%)  2/332 (0.60%) 
Vascular disorders     
Deep vein thrombosis  1/570 (0.18%)  0/332 (0.00%) 
Hypertension  0/570 (0.00%)  1/332 (0.30%) 
Hypotension  1/570 (0.18%)  0/332 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
23 mg SR in Study 326 10 mg IR in Study 326
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   415/570 (72.81%)      259/332 (78.01%)    
Blood and lymphatic system disorders     
Anaemia  2/570 (0.35%)  9/332 (2.71%) 
Gastrointestinal disorders     
Diarrhoea  19/570 (3.33%)  18/332 (5.42%) 
Insomnia  18/570 (3.16%)  12/332 (3.61%) 
Vomiting  9/570 (1.58%)  14/332 (4.22%) 
Constipation  6/570 (1.05%)  8/332 (2.41%) 
General disorders     
Nausea  12/570 (2.11%)  20/332 (6.02%) 
Irritability  13/570 (2.28%)  7/332 (2.11%) 
Oedema peripheral  15/570 (2.63%)  5/332 (1.51%) 
Asthenia  5/570 (0.88%)  11/332 (3.31%) 
Infections and infestations     
Nasopharyngitis  14/570 (2.46%)  11/332 (3.31%) 
Injury, poisoning and procedural complications     
Fall  47/570 (8.25%)  23/332 (6.93%) 
Contusion  9/570 (1.58%)  7/332 (2.11%) 
Investigations     
Weight decreased  57/570 (10.00%)  43/332 (12.95%) 
Weight increased  15/570 (2.63%)  12/332 (3.61%) 
Metabolism and nutrition disorders     
Anorexia  11/570 (1.93%)  10/332 (3.01%) 
Hypercholesterolaemia  10/570 (1.75%)  7/332 (2.11%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  7/570 (1.23%)  8/332 (2.41%) 
Nervous system disorders     
Syncope  13/570 (2.28%)  3/332 (0.90%) 
Dizziness  5/570 (0.88%)  11/332 (3.31%) 
Psychiatric disorders     
Agitation  33/570 (5.79%)  26/332 (7.83%) 
Aggression  28/570 (4.91%)  20/332 (6.02%) 
Depression  15/570 (2.63%)  12/332 (3.61%) 
Anxiety  12/570 (2.11%)  2/332 (0.60%) 
Renal and urinary disorders     
Urinary tract infection  25/570 (4.39%)  18/332 (5.42%) 
Urinary incontinence  12/570 (2.11%)  11/332 (3.31%) 
Respiratory, thoracic and mediastinal disorders     
Cough  7/570 (1.23%)  7/332 (2.11%) 
Vascular disorders     
Hypertension  18/570 (3.16%)  9/332 (2.71%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Andrew Satlin, Senior Vice President, Neuroscience Product Creation Unit
Organization: Eisai, Inc.
Phone: 201-949-4597
EMail: Andrew_Satlin@eisai.com
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00566501     History of Changes
Other Study ID Numbers: E2020-G000-328
2006-004890-93 ( EudraCT Number )
First Submitted: November 29, 2007
First Posted: December 3, 2007
Results First Submitted: May 16, 2012
Results First Posted: June 19, 2012
Last Update Posted: July 11, 2014