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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 1
Kontakter och platser
Studieorter
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Arizona
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Phoenix, Arizona, Förenta staterna, 85013
- Dedicated Phase I
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California
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Long Beach, California, Förenta staterna, 90806
- Collaborative Neuroscience Network
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Florida
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Miami, Florida, Förenta staterna, 33169
- Elite Research Insitute
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Orlando, Florida, Förenta staterna, 32806
- Compass Research, LLC
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Georgia
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Atlanta, Georgia, Förenta staterna, 30308
- Atlanta Center for Medical Research
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Missouri
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St. Louis, Missouri, Förenta staterna, 63118
- St. Louis Clinical Trials, LC
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Texas
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Houston, Texas, Förenta staterna, 77074
- Clinical Trial Network
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Placebo
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Escalating dose
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Aktiv komparator: Multiple Dose
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Escalating dose
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Safety assessments to include pharmacokinetics, and adverse events
Tidsram: 24 hours
|
24 hours
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Abel Murillo, MD, Elite Research Institute
- Huvudutredare: Craig T. Curtis, MD, Compass Research
- Huvudutredare: Kyle Patrick, D.O., Dedicated Phase I
- Huvudutredare: Maxwell Axler, MD, Clinical Trial Network
- Huvudutredare: Ricky S. Mofsen, D.O., St. Louis Clinical Trials, LC
- Huvudutredare: Armen Goenjian, MD, Collaborative Neuroscience Network
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LNK754-0902-1AB
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