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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

This study has been completed.
Sponsor:
Information provided by:
Link Medicine Corporation
ClinicalTrials.gov Identifier:
NCT01013610
First received: November 12, 2009
Last updated: March 14, 2011
Last verified: March 2011

November 12, 2009
March 14, 2011
November 2009
March 2011   (final data collection date for primary outcome measure)
Safety assessments to include pharmacokinetics, and adverse events [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01013610 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Mild Alzheimer's Disease
  • Drug: LNK-754
    Escalating dose
  • Drug: Placebo
    Escalating dose
  • Active Comparator: Multiple Dose
    Intervention: Drug: LNK-754
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
55 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01013610
LNK754-0902-1AB
Yes
Scott Young, Chief Operating Officer, Link Medicine Corporation
Link Medicine Corporation
Not Provided
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
Link Medicine Corporation
March 2011

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