EUCTR2021-004809-40-PT进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- 性别
- All
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 as determined by a neurologist, geriatrician, psychiatrist, or clinician approved by the Sponsor or designee.
- •3.Mild or moderate dementia as evidenced by MMSE score =13 to =24 at screening (Visit 1).
- •4.Imaging studies (MRI or CT) within 2 years prior to screening (or at screening) that has findings consistent with AD and without any other disease that may cause dementia.
- •5.An Aß PET scan or CSF examination performed within 2 years prior to screening (or at screening) with results consistent with the presence of amyloid pathology.
- •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 supervise the participant’s compliance, sees the participant sufficiently to provide meaningful assessment of changes in participant behavior and function over time and provide information on safety and tolerability.
- •10.A male participant must agree to use a highly effective contraception method
- •11.A female participant is eligible to participate if she is not pregnant, not breastfeeding, and not a WOCBP or a WOBCP who agrees to use highly effective contraception method.
- •12.A WOCBP must have a negative serum pregnancy test at screening (Visit 1) and a negative urine pregnancy test at Visit 2 before randomization, and must use medically accepted means of contraception throughout the study.
- •13.Written informed consent provided by participant (or legal representative) and caregiver prior to any study-specific procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
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
- •2.Concurrent or history of schizophrenia or bipolar disorder; OR any other clinically significant psychiatric conditions (eg, schizophrenia or bipolar affective disorder) 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 participant 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 manner that would interfere with cognitive testing, in the opinion of the Investigator. Atypical antipsychotics may be used at the discretion of the Investigator. Tricyclic antidepressants and monoamine oxidase (MAO) inhibitors are prohibited
- •12.Previous treatment with GV1001.
- •13.Received an investigational product for AD within the last 6 months.
- •14.Participated in another clinical study within 4 weeks prior to this study.
- •15.Treated with aducanumab or participated in a clinical study with aducanumab.
- •16.Renal impairment (creatinine clearance [CrCL] <30 mL/min).
- •17.Severe liver dysfunction (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the upper limit of normal [ULN]).
- •18.Body weight =35 kg.
- •19.Resides in a moderate to high dependency continuous care facility (residence in low grade assisted living facility where there is sufficient au
研究者
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