A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Design, Prospective, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Donepezil and Combined With GV1001 in Alzheimer Patients

GemVax & Kael1 site in 1 country96 target enrollmentSeptember 5, 2017

ConditionsAlzheimer Disease

InterventionsNormal Saline 0.9%GV1001 0.56 mg GV1001 1.12 mg

Overview

Phase: Phase 2
Intervention: Normal Saline 0.9%
Conditions: Alzheimer Disease
Sponsor: GemVax & Kael
Enrollment: 96
Locations: 1
Primary Endpoint: SIB (Severe Impairment Battery)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This clinical study is designed as a multi-center, randomized, double-blind, placebo-controlled, parallel design, prospective, phase II clinical trial.

An eligible subject who meets inclusion and exclusion criteria is randomly assigned to three groups: study group 1 (GV1001 0.56 mg), study group 2 (GV1001 1.12 mg) or placebo group. A randomized subject is administered either GV1001 or placebo in a total of 14 times and will be evaluated for the efficacy and safety at week of 24.

Detailed Description

GV1001 0.56 mg, 1.12 mg or placebo is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times. 1. Control group (placebo): 30 subjects 2. Study group 1 (GV1001 0.56 mg): 30 subjects 3. Study group 2 (GV1001 1.12 mg): 30 subjects.

Registry

clinicaltrials.gov

Start Date

September 5, 2017

End Date

September 19, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GemVax & Kael

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•55 to 85 years of age
•A patient who satisfies diagnostic criteria for dementia in DSM-IV
•Probable Alzheimer's disease in NINCDS-ADRDA
•K-MMSE ≤ 19 at screening and randomization visit
•GDS 5\~6 stage
•MRI or CT scan within 12 months prior to screening visit that proves Alzheimer's disease without any other disease that may cause dementia
•A patient taking stable doses of donepezil for more than 3 months before screening visit
•A patient who are able to visit a hospital (including inpatient and outpatient based) and receive cognitive and other tests
•A patient with a caregiver who can accompany all visits and supervise the subject's compliance with the procedures and study drug prescribed in the protocol, and provide detailed information about the patient
•Written informed consent by a patient or legal representative

Exclusion Criteria

•Any other cause of dementia shown by CT / MRI findings and neurological examination within 12 months of screening visit
•Possible, probable or definite vascular dementia according to the NINDS-AIREN
•Other central nervous system diseases that may cause cognitive impairment (cerebrovascular disease including cerebrovascular dementia, Parkinsonism, Huntington's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor, Creutzfeldt-Jakob disease, etc.)
•Neurological deficits such as delusions, delirium, epilepsy
•Vitamin B12, folic acid, syphilis serology, and thyroid stimulating hormone (TSH) results are thought to contribute to the severity of dementia or cause dementia
•A patient who are considered ineligible for this study by investigator due to concurrent or history of significant psychiatric conditions (eg. schizophrenia or bipolar affective disorder)
•A patient with a history of known or suspected seizures including febrile seizures, a history of significant head trauma with loss of consciousness or recent unconsciousness that is not explained
•A patient with acute or unstable cardiovascular disease, active peptic ulcer, uncontrolled hypertension, uncontrolled diabetes or insulin dependent patients or any medical condition that may interfere with the completion of clinical trials
•Hypersensitivity to investigational medicinal products
•History of alcohol, substance abuse or dependence (except nicotine dependence) within the last 2 years

Arms & Interventions

Control group

Normal saline 0.9%

Intervention: Normal Saline 0.9%

Study group 1

GV1001 0.56 mg

Intervention: GV1001 0.56 mg

Study group 2

GV1001 1.12 mg

Intervention: GV1001 1.12 mg

Outcomes

Primary Outcomes

SIB (Severe Impairment Battery)

Time Frame: week 24

Change in SIB compared to the baseline and week 24

Secondary Outcomes

K-MMSE (Korean-Mini-Mental State Examination)(week 24)
CDR-SOB (Clinical Dementia Rating-Sum of Box)(week 24)
ADCS-ADL-severe (Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-severe)(week 24)
NPI (Neuropsychiatric Inventory)(week 24)
GDS (Global Deterioration Scale)(week 24)
CIBIC-plus (Clinician Interview-Based Impression of Change-Plus)(week 24)