- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01013610
An Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNK 754 in Elderly Volunteers and in Subjects With Mild Alzheimer's Disease
A Double-Blind, Randomized, Placebo-Controlled, Multiple, Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNK 754 in Elderly Volunteers and in Subjects With Mild Alzheimer's Disease
연구 개요
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85013
- Dedicated Phase I
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California
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Long Beach, California, 미국, 90806
- Collaborative NeuroScience Network
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Florida
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Miami, Florida, 미국, 33169
- Elite Research Insitute
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Orlando, Florida, 미국, 32806
- Compass Research, LLC
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Georgia
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Atlanta, Georgia, 미국, 30308
- Atlanta Center for Medical Research
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Missouri
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St. Louis, Missouri, 미국, 63118
- St. Louis Clinical Trials, LC
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Texas
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Houston, Texas, 미국, 77074
- Clinical Trial Network
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Part A and Part B:
- Males or females aged 60 years or older. Females must be surgically sterilized or postmenopausal for at least two years. Males must be actively practicing double-barrier contraception (condom plus spermicide), unless they have had a vasectomy, or their partner(s) meet the above criteria for females.
- Voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures.
Be prepared to adhere to the protocol requirements and be willing and able to remain in the study unit for the entire duration of the confinement period. They must also be willing to return for the End-of-Study Visit one week after the last dosing.
Part A only:
Subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. Subjects may be included with clinical deviations from normal limits in medical history, physical examination, vital sign measurements, ECG, or laboratory test results that are associated with stable, well controlled chronic illness. Subjects with concomitant diseases or using concomitant medication will be allowed to participate provided a stable condition and stable treatment for 1 month (30 days) prior to administration of the first dose of study medication. Inclusion of each subject will be reviewed with the Link Medical Monitor prior to enrollment in the trial.
Part B only:
- Subjects with Mild Alzheimer's Disease, as defined by DSM-IV.
- Subjects with a score of ≥ 18-26 on the Mini-Mental State Examination (MMSE).
- Subjects with a Clinical Dementia Rating (CDR) total score of 0.5 or 1.0 (possible or mild dementia).
- Subjects with a Rosen-Modified Hachinski Ischemic score of ≤ 4.
Exclusion Criteria:
Part A and Part B:
- Any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease, as determined by medical history, physical examination or laboratory tests.
- Subjects who have positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- Subjects who have received any experimental drugs or devices within 30 days prior to dosing or who wish to receive any experimental drug within 30 days after completing the study.
- Subjects unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약
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Escalating dose
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활성 비교기: Multiple Dose
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Escalating dose
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Safety assessments to include pharmacokinetics, and adverse events
기간: 24 hours
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24 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Abel Murillo, MD, Elite Research Institute
- 수석 연구원: Craig T. Curtis, MD, Compass Research
- 수석 연구원: Kyle Patrick, D.O., Dedicated Phase I
- 수석 연구원: Maxwell Axler, MD, Clinical Trial Network
- 수석 연구원: Ricky S. Mofsen, D.O., St. Louis Clinical Trials, LC
- 수석 연구원: Armen Goenjian, MD, Collaborative NeuroScience Network
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
LNK-754에 대한 임상 시험
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Link Medicine Corporation완전한
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Lynk Pharmaceuticals Co., Ltd빼는급성 골수성 백혈병 | 원발성 골수 섬유증 | 진성적혈구증가증 | 적혈구증가증 후 Vera Myelofibrosis | 후본태성 혈소판증가증 골수 섬유증미국
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Assistance Publique - Hôpitaux de Paris완전한
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Medtronic Diabetes완전한제2형 당뇨병미국, 프랑스, 독일, 오스트리아, 캐나다, 헝가리, 이스라엘, 이탈리아, 마케도니아, 구 유고슬라비아 공화국, 네덜란드, 세르비아, 남아프리카, 스페인