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

NCT02097056 | Completed Phase 4 Results

• 1 other identifier: ART-M082-401
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 13

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Overall Summary of Adverse Events (AEs)

  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.

  Baseline (Day 1) up to Week 24

Secondary Outcomes (2)

• Change From Baseline in the Mini-Mental State Examination (MMSE) Score

  Baseline, Week 12, and Week 24 (Final visit)

• Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores

  Baseline, Week 12, and Week 24 (Follow up visit)

Study Arms (1)

donepezil HCl 23 mg

EXPERIMENTAL

Donepezil HCl 23 mg once daily, just before bed, for 24 weeks

Drug: Donepezil HCL

Interventions

Donepezil HCL DRUG

Donepezil HCl 23 mg once daily, just before bed, for 24 weeks

donepezil HCl 23 mg

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 45 to 90 years
• Patients have eligible conditions of dementia diagnosis listed in DSM-IV
• Diagnosed as a probable Alzheimer's Disease patient according to NINCDS-ADRDA criteria
• 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
• 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
• 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)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (13)

Unknown Facility

Ansan, Gyeonggi-do, South Korea

Location

Unknown Facility

Buchoen, Gyeonggi-do, South Korea

Location

Unknown Facility

Seongnam-si, Gyeonggi-do, South Korea

Location

Unknown Facility

Jinju, Gyeongsangnam-do, South Korea

Location

Unknown Facility

Iksan, Jeollabuk-do, South Korea

Location

Unknown Facility

Hwasun, Jeollanam-do, South Korea

Location

Unknown Facility

Busan, Korea, Republic of, South Korea

Location

Unknown Facility

Daegu, Korea, Republic of, South Korea

Location

Unknown Facility

Daejeon, Korea, Republic of, South Korea

Location

Unknown Facility

Incheon, Korea, Republic of, South Korea

Location

Unknown Facility

Jeju City, Korea, Republic of, South Korea

Location

Unknown Facility

Seoul, Korea, Republic of, South Korea

Location

Unknown Facility

Chungju, North Chungcheong, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Youngji Pyo
• Organization: Eisai Korea Inc.

y-pyo@eisaikorea.com

+82-2-3451-5533

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 27, 2016
• Results First Posted: June 27, 2016

Record last verified: 2016-05

Locations

KR (13)