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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85013
- Dedicated Phase I
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California
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Long Beach, California, Forente stater, 90806
- Collaborative Neuroscience Network
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Florida
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Miami, Florida, Forente stater, 33169
- Elite Research Insitute
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Orlando, Florida, Forente stater, 32806
- Compass Research, LLC
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Georgia
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Atlanta, Georgia, Forente stater, 30308
- Atlanta Center for Medical Research
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Missouri
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St. Louis, Missouri, Forente stater, 63118
- St. Louis Clinical Trials, LC
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Texas
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Houston, Texas, Forente stater, 77074
- Clinical Trial Network
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Safety assessments to include pharmacokinetics, and adverse events
Tidsramme: 24 hours
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24 hours
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Abel Murillo, MD, Elite Research Institute
- Hovedetterforsker: Craig T. Curtis, MD, Compass Research
- Hovedetterforsker: Kyle Patrick, D.O., Dedicated Phase I
- Hovedetterforsker: Maxwell Axler, MD, Clinical Trial Network
- Hovedetterforsker: Ricky S. Mofsen, D.O., St. Louis Clinical Trials, LC
- Hovedetterforsker: Armen Goenjian, MD, Collaborative Neuroscience Network
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LNK754-0902-1AB
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