Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01478633
First received: November 3, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate the efficacy and safety of galantamine in patients who failed to benefit from donepezil (patients switching from donepezil). In clinical practice, it is expected that galantamine will be used in patients switching from donepezil due to the insufficient efficacy of donepezil.


Condition Intervention Phase
Alzheimer's Disease
Drug: Galantamine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Galantamine in Subjects With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • The Change from Baseline in Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) Score at Week 24 [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
    The ADAS-J cog scale assesses memory, language and behavior and is composed of 11 tasks: word recall, spoken language ability, auditory comprehension, word finding difficulty in spontaneous speech, following commands, object and finger naming, constructional praxis, ideational praxis, orientation, word recognition, and recalling test instructions. The perfect total score is 70 points, and as the score becomes higher, the degree of impairment becomes severer.


Secondary Outcome Measures:
  • The Clinical Global Impression of Change (CGI-C) at Week 24 [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
    CGI-C is employed to evaluate the patient's global clinical improvement according to the rater's impression from 1 (Very much improved) to 7 (Very much worse).

  • Proportion of Responders at Week 24 [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
    Proportion of responders whose ADAS-J cog score at endpoint decreased from baseline.


Enrollment: 102
Study Start Date: September 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Galantamine Drug: Galantamine
8 mg/day (4 mg twice daily) for 4 weeks, followed by 16 mg/day (8 mg twice daily) for an additional 4 weeks, followed by dose at 16 mg or increased to 24 mg (with the option of decreasing back to 16 mg) for the remainder of the study (to week 24)

Detailed Description:

This is a nonrandomized (study drug is intentionally assigned), open-label (all people involved know the identity of the intervention), single-arm (one group of patients receiving the same treatment), multi-centered study of galantamine in patients with Alzheimer's disease (AD). Galantamine has been approved for treatment of mild to moderate dementia of AD. Galantamine is available as film-coated tablet in 68 countries including the United States and Europe, and is also available as oral syrup and extended-release capsule in 65 counties. In Japan, galantamine was approved in January 2011 and is available in three dosage forms of film-coated tablet, oral disintegrant tablet, and oral syrup. The target population is patients with mild to moderate dementia of Alzheimer's type (ie, Mini-Mental State Examination [MMSE] ranging from 10 to 22) who failed to benefit from donepezil. Patients must have diagnosis of probable AD according to the diagnostic criteria National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) study group. To ensure that at least 100 subjects complete the study, 125 subjects will be enrolled. The treatment group is to receive flexible dosing of 16 mg/day or 24 mg/day. Patients will receive the study treatment for 24 weeks in accordance with the dosing regimen specified in the protocol.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have diagnosis of probable Alzheimer's disease (AD) in accordance with the diagnostic criteria of NINCDS-ADRDA study group
  • Have an MMSE score of 10 to 22 inclusive at screening
  • Have taken donepezil stably at 5 mg/day for more than 6 months before screening
  • Have progression (worsening) of impaired cognitive function 6 months or longer before screening
  • Be considered medically stable by the investigator on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
  • Be medically stable on the basis of clinical laboratory tests performed at screening

Exclusion Criteria:

  • Has any concurrent neurodegenerative diseases manifesting dementia other than Dementia of Alzheimer's type
  • Has suspected impaired cognitive function due to a variety of causes
  • Has significant health disorders or diseases according to the investigators' detailed criteria
  • Has had major surgery within 52 weeks of screening, or will not have fully recovered from surgery, or planned surgery during the time the subject is expected to participate in the study
  • Is a woman who is pregnant, or breast-feeding, or planning to become pregnant or is a man who plans to father a child while enrolled in this study
  • Has a history of severe drug allergy or severe drug hypersensitivity
  • Has a history of drug or alcohol abuse
  • Used another investigational drug within 90 days of screening
  • Used anti-dementia drugs marketed or being developed other than donepezil or medications containing the same active ingredients within 6 months of screening
  • Is considered as ineligible by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478633

Locations
Japan
Akita, Japan
Izunokuni, Japan
Kochi N/A, Japan
Kumamoto, Japan
Osaka, Japan
Saitama N/A, Japan
Takatsuki, Japan
Tokyo, Japan
Uji, Japan
Urayasu, Japan
Yokohama, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K. K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01478633     History of Changes
Other Study ID Numbers: CR018649, JNS023-JPN-02
Study First Received: November 3, 2011
Last Updated: March 24, 2014
Health Authority: Japan: Pharmaceuticals and Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Alzheimer's disease
Dementia
Galantamine
Donepezil

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Galantamine
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014