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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85013
- Dedicated Phase I
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California
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Long Beach, California, Verenigde Staten, 90806
- Collaborative Neuroscience Network
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Florida
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Miami, Florida, Verenigde Staten, 33169
- Elite Research Insitute
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Orlando, Florida, Verenigde Staten, 32806
- Compass Research, LLC
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30308
- Atlanta Center for Medical Research
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Missouri
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St. Louis, Missouri, Verenigde Staten, 63118
- St. Louis Clinical Trials, LC
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Texas
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Houston, Texas, Verenigde Staten, 77074
- Clinical Trial Network
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo
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Escalating dose
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Actieve vergelijker: Multiple Dose
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Escalating dose
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Safety assessments to include pharmacokinetics, and adverse events
Tijdsspanne: 24 hours
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24 hours
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Abel Murillo, MD, Elite Research Institute
- Hoofdonderzoeker: Craig T. Curtis, MD, Compass Research
- Hoofdonderzoeker: Kyle Patrick, D.O., Dedicated Phase I
- Hoofdonderzoeker: Maxwell Axler, MD, Clinical Trial Network
- Hoofdonderzoeker: Ricky S. Mofsen, D.O., St. Louis Clinical Trials, LC
- Hoofdonderzoeker: Armen Goenjian, MD, Collaborative Neuroscience Network
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- LNK754-0902-1AB
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