NL-OMON53512尚未招募2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Prospective, 52-Week, Phase 2 Clinical Study to Evaluate the Safety and Efficacy of GV1001 Administered Subcutaneously for the Treatment of Mild to Moderate Alzheimer*s Disease - GV1001 SC for the Treatment of Mild to Moderate (Stage 4 and 5) AD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female participants 55 to 85 years of age (both inclusive) at the
- •time of signing the informed consent.
- •2. Diagnosis of probable AD based on NINCDS-ADRDA criteria (a and b) as
- •determined by a neurologist, geriatrician, psychiatrist, or clinician approved
- •by the Sponsor or designee.
- •a. Presence of an early and significant episodic memory impairment that
- •includes the following features:
- •i. Gradual and progressive change in memory function reported by patients or
- •informants over >6 months.
- •ii. Objective evidence of significantly impaired episodic memory on testing:
- •this generally consists of recall deficit that does not improve
- •significantly or does not normalize with cueing or recognition testing and
- •after effective encoding of information has been previously controlled.
- •iii. The episodic memory impairment can be isolated or associated with other
- •cognitive changes at the onset of AD or as AD advances.
- •b. One or more findings for probable AD by either MRI, Aβ PET scan, historical
- •CSF results, or a historical genetic test in the 2 years before screening, or
- •an MRI or Aβ PET scan at screening. The MRI must have findings consistent with
- •AD and without any other disease that may cause dementia. The Aβ PET scan and
- •historical CSF results must be consistent with the presence of amyloid
- •3. Mild or moderate dementia as evidenced by MMSE score >=13 to <=24 at screening
- •(Visit 1).
- •4. not applicable.
- •5. not applicable.
- •6. If receiving an approved medication for AD (ie, donepezil, galantamine,
- •rivastigmine, memantine, or memantine/donepezil combination product), must be
- •on the medication with a stable dose for at least 12 weeks before the screening
- •visit (dosing should remain stable throughout the study).
- •7. If receiving an OTC supplement for cognition (eg, gingko biloba, omega-3
- •polyunsaturated fatty acid, vitamin E, curcumin), must not be exceeding the
- •recommended dose for at least 12 weeks prior to screening visit.
- •8. Able to visit the study center and undergo cognitive, functional, and other
- •tests specified in the protocol.
- •9. Has a caregiver who:
- •Agrees to accompany the participant to all study visits and able to supervise
- •the participant's compliance with the study procedures and
- •provide detailed information about the participant.
- •Either lives with the participant or sees the participant on average for >=1
- •hour/day >=3 days/week, or in the Investigator's opinion, the extent of contact
- •is sufficient to provide meaningful assessment of changes in participant
- •behavior and function over time and provide information on safety and
- •tolerability.
- •Is able to read, understand, and speak the designated language at the study
- •Caregiver must be cognitively able to fulfill the requirements of the study.
- •For a full list of inclusion criteria, please refer to the protocol.
排除标准
- •1. Any other cause of dementia shown by MRI/CT findings within 2 years of
- •screening (or at screening) and neurological examination at screening and Day
- •1. • Possible, probable, or definite vascular dementia according to the
- •National Institute of Neurological Disorders and Stroke and Association
- •Internationale pour la Recherche* et l*Enseignement en Neurosciences
- •(NINDS-AIREN) criteria. • Evidence of significant abnormality that would
- •suggest another potential etiology for dementia (eg, evidence of cerebral
- •contusion, encephalomalacia, aneurysm, vascular malformation, >5
- •microhemorrhages, macrohemorrhage, single infarct >1 cm3). • Other central
- •nervous system diseases that may cause cognitive impairment (eg,
- •cerebrovascular disease including cerebrovascular dementia, Parkinsonism,
- •Huntington*s disease, subdural hematoma, normal pressure hydrocephalus, brain
- •tumor, Creutzfeldt-Jakob disease). 2. Concurrent or history of schizophrenia or
- •bipolar affective disorder; OR any other clinically significant psychiatric
- •condition that in the Investigator*s opinion prevents the participant from
- •participating, or is likely to confound interpretation of drug effect or affect
- •cognitive assessments or patients safety. OR the presence or history of
- •suicidal attempts or suicidal ideation evidenced by endorsing Items 4 or 5 of
- •the C-SSRS at screening or Day 1, endorsing any suicidal behavior item on the
- •C-SSRS Since Last Visit form on Day 1, or any suicide attempt within 2 years
- •prior to screening. 3. Vitamin B12, folic acid, syphilis serology, and thyroid
- •stimulating hormone (TSH) results that are thought to contribute to the
- •severity of dementia or cause dementia. Participants may be enrolled if in the
- •Investigator*s medical judgment, the abnormal laboratory values are not the
- •cause of the cognitive symptoms. 4. History of known or suspected seizures
- •including febrile seizures (excluding self-limited childhood febrile seizures),
- •a history of significant head trauma with loss of consciousness or recent
- •unconsciousness that is not explained. 5. 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 the clinical study. 6. Known allergies, hypersensitivity, or
- •intolerance to GV1001 or similar products or excipients. 7. History of alcohol,
- •substance abuse or dependence as per DSM-V criteria (except nicotine
- •dependence) within the last 2 years. 8. Concurrent malignancies or invasive
- •cancers diagnosed within the past 5 years except for adequately treated
- •non-metastatic basal cell carcinoma or squamous cell carcinoma of skin, in situ
- •carcinoma of the uterine cervix or non-metastatic prostate cancer. 9.
- •Sexually-active WOCBP or man capable of fathering a child who do not consent to
- •using medicinally acceptable contraception (such as surgical sterilization,
- •intrauterine contraceptive device, condom or diaphragm, an injectable or
- •inserted contraceptive) during the study and for 3 months after the last dose
- •of study treatment. 10. Pregnant, breast feeding, or planning a pregnancy or
- •fathering a child while enrolled in the study or for 3 months after the last
- •dose of study treatment. 11. Use of anxiolytics, narcotics, or sleep aids in a
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