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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)

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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. )

Brief Summary:
This is a multi-center, open-label, single-arm, prospective, phase IV trial, evaluating safety and efficacy of donepezil hydrochloride in patients with moderate to severe Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Donepezil HCL Phase 4

Detailed Description:
This study consisted of pre-treatment and treatment phase. Pre-treatment phase was approximately 4 weeks including the screening and baseline process. In treatment phase, about 190 subjects received Donepezil HCl 23 mg once daily for 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease
Study Start Date : February 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Experimental: donepezil HCl 23 mg
Donepezil HCl 23 mg once daily, just before bed, for 24 weeks
Drug: Donepezil HCL
Donepezil HCl 23 mg once daily, just before bed, for 24 weeks




Primary Outcome Measures :
  1. Overall Summary of Adverse Events (AEs) [ Time Frame: Baseline (Day 1) up to Week 24 ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in the Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline, Week 12, and Week 24 (Final visit) ]
    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.

  2. Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores [ Time Frame: Baseline, Week 12, and Week 24 (Follow up visit) ]
    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.



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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Male or female aged 45 to 90 years
  2. Patients have eligible conditions of dementia diagnosis listed in DSM-IV
  3. Diagnosed as a probable Alzheimer's Disease patient according to NINCDS-ADRDA criteria
  4. At the timing of screening, MMSE less than or equal to 20 AND CDR greater than or equal to 2 OR GDS greater than or equal to 4
  5. Patients, who have been taking stable donepezil 10 mg for 3 months or longer before the start of the study (screening visit), are evaluated as eligible to take donepezil 23 mg by investigator
  6. Patients who have not received any other medications for AD such as AChE inhibitors at least for 3 months prior to the screening visit excluding donepezil hydrochloride (However, concomitant use of memantine is allowed if taken at stable dose that are less than or equal to the approved dose range for at least 3 months prior to screening)
  7. Medicines for cerebral activation such as Gingko Biloba is allowed to be taken if the patient has received it as stable dose for 3 months prior to the screening visit

Exclusion Criteria

  1. Patients who have been participated in any other clinical trial 3 months prior to the screening visit
  2. Patients who are having any severe psychiatric disorder or schizophrenia
  3. Patients who are having a neurological disorder other than AD which affect the subject's cognition or ability to assess the cognition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097056


Locations
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Korea, Republic of
Chungju, Chungcheongbuk-do, Korea, Republic of
Ansan, Gyeonggi-do, Korea, Republic of
Buchoen, Gyeonggi-do, Korea, Republic of
Seongnam, Gyeonggi-do, Korea, Republic of
Jinju, Gyeongsangnam-do, Korea, Republic of
Iksan, Jeollabuk-do, Korea, Republic of
Hwasun, Jeollanam-do, Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Incheon, Korea, Republic of
Jeju, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Eisai Korea Inc.

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Responsible Party: Eisai Korea Inc.
ClinicalTrials.gov Identifier: NCT02097056     History of Changes
Other Study ID Numbers: ART-M082-401
First Posted: March 26, 2014    Key Record Dates
Results First Posted: June 27, 2016
Last Update Posted: June 27, 2016
Last Verified: May 2016
Keywords provided by Eisai Inc. ( Eisai Korea Inc. ):
Alzheimer's disease
Additional relevant MeSH terms:
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Donepezil
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents