Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01013610
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : March 15, 2011
Sponsor:
Information provided by:
Link Medicine Corporation

Tracking Information
First Submitted Date  ICMJE November 12, 2009
First Posted Date  ICMJE November 16, 2009
Last Update Posted Date March 15, 2011
Study Start Date  ICMJE November 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2009)
Safety assessments to include pharmacokinetics, and adverse events [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary To evaluate the safety, tolerability, multiple dose plasma pharmacokinetics (PK) of LNK-754 in male and female elderly volunteers after dosing with LNK-754 for 7 days and in subjects with mild Alzheimer's Disease after dosing with LNK-754 for 28 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Mild Alzheimer's Disease
Intervention  ICMJE
  • Drug: LNK-754
    Escalating dose
  • Drug: Placebo
    Escalating dose
Study Arms  ICMJE
  • Active Comparator: Multiple Dose
    Intervention: Drug: LNK-754
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 13, 2009)
110
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Part A and Part B:

  1. 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.
  2. Voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures.
  3. 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:

  4. 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:

  5. Subjects with Mild Alzheimer's Disease, as defined by DSM-IV.
  6. Subjects with a score of ≥ 18-26 on the Mini-Mental State Examination (MMSE).
  7. Subjects with a Clinical Dementia Rating (CDR) total score of 0.5 or 1.0 (possible or mild dementia).
  8. Subjects with a Rosen-Modified Hachinski Ischemic score of ≤ 4.

Exclusion Criteria:

Part A and Part B:

  1. 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.
  2. Subjects who have positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
  3. 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.
  4. Subjects unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01013610
Other Study ID Numbers  ICMJE LNK754-0902-1AB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott Young, Chief Operating Officer, Link Medicine Corporation
Study Sponsor  ICMJE Link Medicine Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Riesenberg, MD Atlanta Center for Medical Research
Principal Investigator: Abel Murillo, MD Elite Research Institute
Principal Investigator: Craig T. Curtis, MD Compass Research
Principal Investigator: Kyle Patrick, D.O. Dedicated Phase I
Principal Investigator: Maxwell Axler, MD Clinical Trial Network
Principal Investigator: Ricky S. Mofsen, D.O. St. Louis Clinical Trials, LC
Principal Investigator: Armen Goenjian, MD Collaborative Neuroscience Network
PRS Account Link Medicine Corporation
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP