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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. )

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE March 26, 2014
Results First Submitted Date  ICMJE March 30, 2016
Results First Posted Date  ICMJE June 27, 2016
Last Update Posted Date June 27, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
Safety of Donepezil HCl 23 mg once daily [ Time Frame: Baseline up to Week 24 ]
Safety will be evaluated by all adverse events, serious adverse events, discontinuation from the treatment, prior and concomitant medication, clinical laboratory determinations (biochemistry, blood, urine test), vital signs, weight, ECG, and physical examination.
Change History Complete list of historical versions of study NCT02097056 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
Efficacy of Donepezil HCl 23 mg once daily [ Time Frame: Baseline, Week 12, and Week 24 (Final visit) ]
MMSE (Mini-Mental State Examination) and NPI-Q (Brief questionnaire form of the Neuropsychiatric Inventory) score will be used to evaluate efficacy. Mean change will be analyzed by paired t-test or Wilcoxon's signed rank test.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease
Official Title  ICMJE Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: Donepezil HCL
Donepezil HCl 23 mg once daily, just before bed, for 24 weeks
Study Arms  ICMJE Experimental: donepezil HCl 23 mg
Donepezil HCl 23 mg once daily, just before bed, for 24 weeks
Intervention: Drug: Donepezil HCL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2015)
171
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2014)
190
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02097056
Other Study ID Numbers  ICMJE ART-M082-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc. ( Eisai Korea Inc. )
Study Sponsor  ICMJE Eisai Korea Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eisai Inc.
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP