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

NCT01478633 | Completed Phase 4

• 2 other identifiers: CR018649JNS023-JPN-02
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; Dementia; Galantamine; Donepezil

Outcome Measures

Primary Outcomes (1)

• The Change from Baseline in Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) Score at Week 24

  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.

  at Week 24

Secondary Outcomes (2)

• The Clinical Global Impression of Change (CGI-C) at Week 24

  at Week 24

• Proportion of Responders at Week 24

  at Week 24

Study Arms (1)

Galantamine

EXPERIMENTAL

Drug: Galantamine

Interventions

Galantamine DRUG

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)

Galantamine

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (11)

Unknown Facility

Akita, Japan

Location

Unknown Facility

Izunokuni, Japan

Location

Unknown Facility

Kochi, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Saitama, Japan

Location

Unknown Facility

Takatsuki, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Uji, Japan

Location

Unknown Facility

Urayasu, Japan

Location

Unknown Facility

Yokohama, Japan

Location

Related Links

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

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Galantamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Janssen Pharmaceutical K. K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

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: November 3, 2011
• First Posted: November 23, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

JP (11)