Clinical Trials List
Protocol NumberE2020-G000-328
NCT Number(ClinicalTrials.gov Identfier)NCT00566501
2008-12-15 - 2010-12-31
Phase III
Terminated3
ICD-10G30.0
Alzheimer's disease with early onset
ICD-10G30.1
Alzheimer's disease with late onset
ICD-10G30.8
Other Alzheimer's disease
ICD-10G30.9
Alzheimer's disease, unspecified
ICD-9331.0
Alzheimer's disease
Open-Label Extension Study of 23 mg Donepezil SR in Patients with Moderate to Severe Alzheimer’s Disease.
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Sponsor
Eisai
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
- 徐海蓓 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chien-Hsun Li Division of Neurology
- MEI-CHUAN CHOU Division of Neurology
- Chiou-Lian Lai Division of Neurology
- Yuan-Han Yang Division of Neurology
The Actual Total Number of Participants Enrolled
8 Terminated
Co-Principal Investigator
- 林書漢 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Alzheimer's disease
Objectives
The purpose of this trial is to evaluate the long-term safety and efficacy of 23 mg Donepezil sustained-release in the treatment of patients with moderate to severe Alzheimer's disease.
Test Drug
Donepezil SR 23mg
Active Ingredient
Donepezil HCL
Dosage Form
Tablet, SR
Dosage
100 mg / 200 mg / 400 mg
Endpoints
SIB (patient's cognitive function), MMSE (patient's cognitive function), ADCS-ADL (patient's functional ability), QoL-AD and EQ-5D (quality of life), SCB (burden by non-professional caregivers), TOS ( Treatment results), GAtS (caregiver and patient treatment goals)
Inclution Criteria
Inclusion conditions:
1) The consent form of the subject will be signed by the patient (if possible) or the legal guardian or other legal representative of the patient before the screening visit. Even if the signed subject consent form cannot be obtained, the patient must verbally agree to participate in this clinical trial, and this consent process should be added to the medical record.
2) Age range: 45 to 91 years old adults.
3) Complete test E2020-G000-326, and there are no progressive serious adverse reactions, or no serious adverse drug reactions occurred during the test. Patients must complete the E2020-G000-326 trial and join the trial within 7 days.
4) Health status: normal physical health and mobility (ambulatory) or those who need assistive devices (such as walking aids or walking sticks); corrected vision and hearing are sufficient to complete the test procedure.
5) The clinical test value must be within the normal range. If there is an abnormal value, the research physician must judge it as not clinically significant.
6) Patients with risk factors for hypertension or heart disease can participate in this clinical trial. If hypertension can be controlled by drugs (diastolic blood pressure <95 mm Hg) and heart diseases (such as angina, chronic congestive heart failure, right tract) Branch conduction obstruction or arrhythmia) showed a stable state under appropriate medical treatment 3 months before the screening visit. Peripheral vascular disease must be under stable control 3 months before the screening visit.
7) Patients with diabetes or diabetes risk factors can participate in this clinical trial, provided the patient’s condition is stable and has not been due to diabetic ketoacidosis or hyperosmolar coma in the near future (within 3 months). Hyperosmolar coma) or hypoglycemia (hypoglycemia) was hospitalized. Non-insulin-dependent patients controlled by diet or oral medications can also participate in this clinical trial.
8) During the screening visit, all diabetic patients must have HbA1c concentration <10% and fasting (8 hours) serum glucose concentration <170 mg/dL or random serum glucose concentration <250 mg/dL.
9) The patient is taking a selective serotonin recovery inhibitor (SSRI) (escitalopram daily dose 10 mg, citalopram or fluoxetine daily dose 20 mg, paroxetine daily dose 30 mg, sertraline daily dose <50 mg or fluvoxamine daily A dose of 100 mg) can participate in this clinical trial, provided that the dose of selective serotonin recovery inhibitor (SSRI) is stable for at least three months before the screening visit.
1) The consent form of the subject will be signed by the patient (if possible) or the legal guardian or other legal representative of the patient before the screening visit. Even if the signed subject consent form cannot be obtained, the patient must verbally agree to participate in this clinical trial, and this consent process should be added to the medical record.
2) Age range: 45 to 91 years old adults.
3) Complete test E2020-G000-326, and there are no progressive serious adverse reactions, or no serious adverse drug reactions occurred during the test. Patients must complete the E2020-G000-326 trial and join the trial within 7 days.
4) Health status: normal physical health and mobility (ambulatory) or those who need assistive devices (such as walking aids or walking sticks); corrected vision and hearing are sufficient to complete the test procedure.
5) The clinical test value must be within the normal range. If there is an abnormal value, the research physician must judge it as not clinically significant.
6) Patients with risk factors for hypertension or heart disease can participate in this clinical trial. If hypertension can be controlled by drugs (diastolic blood pressure <95 mm Hg) and heart diseases (such as angina, chronic congestive heart failure, right tract) Branch conduction obstruction or arrhythmia) showed a stable state under appropriate medical treatment 3 months before the screening visit. Peripheral vascular disease must be under stable control 3 months before the screening visit.
7) Patients with diabetes or diabetes risk factors can participate in this clinical trial, provided the patient’s condition is stable and has not been due to diabetic ketoacidosis or hyperosmolar coma in the near future (within 3 months). Hyperosmolar coma) or hypoglycemia (hypoglycemia) was hospitalized. Non-insulin-dependent patients controlled by diet or oral medications can also participate in this clinical trial.
8) During the screening visit, all diabetic patients must have HbA1c concentration <10% and fasting (8 hours) serum glucose concentration <170 mg/dL or random serum glucose concentration <250 mg/dL.
9) The patient is taking a selective serotonin recovery inhibitor (SSRI) (escitalopram daily dose 10 mg, citalopram or fluoxetine daily dose 20 mg, paroxetine daily dose 30 mg, sertraline daily dose <50 mg or fluvoxamine daily A dose of 100 mg) can participate in this clinical trial, provided that the dose of selective serotonin recovery inhibitor (SSRI) is stable for at least three months before the screening visit.
Exclusion Criteria
Exclude conditions:
1) The caregiver does not meet the conditions for inclusion of the caregiver.
2) People with mental problems that affect the assessment of cognitive ability, such as patients with schizophrenia, bipolar or unipolar depression. Patients with clinically significant sleep disorders are also excluded, unless their sleep status has been controlled before the screening visit and the condition is stable for more than (>) 3 months.
3) The patient has dementia accompanied by other organic diseases or Alzheimer's disease and delirium (according to DSM IV 290.30 or 290.11).
4) The patient has an existing or clinically significant condition that can affect the absorption, distribution or metabolism of the test drug (such as inflammatory bowel disease, gastric or duodenal ulcer, liver disease, or severe lactose deficiency).
5) The patient has clinically significant evidence of existing gastrointestinal tract, kidney, liver, respiratory tract, endocrine or cardiovascular disease.
6) Existing evidence shows that the patient has a malignant tumor (excluding skin basal cell epithelioma and squamous cell carcinoma). Male patients with localized prostate cancer and do not need treatment will not be excluded from this condition
7) During the trial period, it is planned to perform surgery that requires general anesthesia and neuromuscular depressants, such as succinylcholine, which will cause paralysis or muscle relaxation. As long as minor operations that do not require the use of anesthetics, such as colonoscopy or cataract surgery, will be allowed to participate in this trial.
8) Patients who are not willing to participate or cannot cooperate with the conditions of this clinical trial.
9) Before or currently taking banned drugs.
10) According to the research physician's judgment, there is any situation that the patient is not suitable to participate in this trial.
11) It is known that patients are taking concomitant antidepressants with significant anticholinergic effects, such as tricyclic antidepressants used in the treatment of severe depressive patients within the recommended dosage range.
12) Patients who cannot swallow or have difficulty swallowing whole tablets.
1) The caregiver does not meet the conditions for inclusion of the caregiver.
2) People with mental problems that affect the assessment of cognitive ability, such as patients with schizophrenia, bipolar or unipolar depression. Patients with clinically significant sleep disorders are also excluded, unless their sleep status has been controlled before the screening visit and the condition is stable for more than (>) 3 months.
3) The patient has dementia accompanied by other organic diseases or Alzheimer's disease and delirium (according to DSM IV 290.30 or 290.11).
4) The patient has an existing or clinically significant condition that can affect the absorption, distribution or metabolism of the test drug (such as inflammatory bowel disease, gastric or duodenal ulcer, liver disease, or severe lactose deficiency).
5) The patient has clinically significant evidence of existing gastrointestinal tract, kidney, liver, respiratory tract, endocrine or cardiovascular disease.
6) Existing evidence shows that the patient has a malignant tumor (excluding skin basal cell epithelioma and squamous cell carcinoma). Male patients with localized prostate cancer and do not need treatment will not be excluded from this condition
7) During the trial period, it is planned to perform surgery that requires general anesthesia and neuromuscular depressants, such as succinylcholine, which will cause paralysis or muscle relaxation. As long as minor operations that do not require the use of anesthetics, such as colonoscopy or cataract surgery, will be allowed to participate in this trial.
8) Patients who are not willing to participate or cannot cooperate with the conditions of this clinical trial.
9) Before or currently taking banned drugs.
10) According to the research physician's judgment, there is any situation that the patient is not suitable to participate in this trial.
11) It is known that patients are taking concomitant antidepressants with significant anticholinergic effects, such as tricyclic antidepressants used in the treatment of severe depressive patients within the recommended dosage range.
12) Patients who cannot swallow or have difficulty swallowing whole tablets.
The Estimated Number of Participants
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Taiwan
31 participants
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Global
1600 participants
