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.

Study Overview

• Status: Completed
• Conditions: Mild Alzheimer's Disease
• Intervention / Treatment: Drug: LNK-754; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Dedicated Phase I
  • California
    • Long Beach, California, United States, 90806
      • Collaborative NeuroScience Network
  • Florida
    • Miami, Florida, United States, 33169
      • Elite Research Insitute
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
  • Missouri
    • St. Louis, Missouri, United States, 63118
      • St. Louis Clinical Trials, LC
  • Texas
    • Houston, Texas, United States, 77074
      • Clinical Trial Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Escalating dose
Active Comparator: Multiple Dose	Drug: LNK-754; Escalating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety assessments to include pharmacokinetics, and adverse events	24 hours

Collaborators and Investigators

• Sponsor: Link Medicine Corporation
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: November 12, 2009
• First Submitted That Met QC Criteria: November 13, 2009
• First Posted (Estimate): November 16, 2009

Study Record Updates

• Last Update Posted (Estimate): March 15, 2011
• Last Update Submitted That Met QC Criteria: March 14, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Healthy Elderly Volunteers
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: LNK754-0902-1AB