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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
  Purpose

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.


Condition Intervention Phase
Mild Alzheimer's Disease
Drug: LNK-754
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Link Medicine Corporation:

Primary Outcome Measures:
  • Safety assessments to include pharmacokinetics, and adverse events [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multiple Dose Drug: LNK-754
Escalating dose
Placebo Comparator: Placebo Drug: Placebo
Escalating dose

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013610

Locations
United States, Arizona
Dedicated Phase I
Phoenix, Arizona, United States, 85013
United States, California
Collaborative Neuroscience Network
Long Beach, California, United States, 90806
United States, Florida
Elite Research Insitute
Miami, Florida, United States, 33169
Compass Research, LLC
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Missouri
St. Louis Clinical Trials, LC
St. Louis, Missouri, United States, 63118
United States, Texas
Clinical Trial Network
Houston, Texas, United States, 77074
Sponsors and Collaborators
Link Medicine Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: Scott Young, Chief Operating Officer, Link Medicine Corporation
ClinicalTrials.gov Identifier: NCT01013610     History of Changes
Other Study ID Numbers: LNK754-0902-1AB
Study First Received: November 12, 2009
Last Updated: March 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Link Medicine Corporation:
Healthy Elderly Volunteers

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2014