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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

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. Identifier: NCT01013610
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : March 15, 2011
Information provided by:
Link Medicine Corporation

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.

Condition or disease Intervention/treatment Phase
Mild Alzheimer's Disease Drug: LNK-754 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Multiple Dose Drug: LNK-754
Escalating dose

Placebo Comparator: Placebo Drug: Placebo
Escalating dose

Primary Outcome Measures :
  1. Safety assessments to include pharmacokinetics, and adverse events [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01013610

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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
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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
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Responsible Party: Scott Young, Chief Operating Officer, Link Medicine Corporation Identifier: NCT01013610    
Other Study ID Numbers: LNK754-0902-1AB
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: March 15, 2011
Last Verified: March 2011
Keywords provided by Link Medicine Corporation:
Healthy Elderly Volunteers
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders