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

NCT ID: NCT01013610

Last Updated: 2011-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-03-31

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.

Conditions

Mild Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Multiple Dose

Group Type: ACTIVE_COMPARATOR

LNK-754

Intervention Type: DRUG

Escalating dose

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Escalating dose

Interventions

LNK-754

Escalating dose

Intervention Type: DRUG

Placebo

Escalating dose

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Link Medicine Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Link Medicine Corporation

Principal Investigators

Robert Riesenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Atlanta Center for Medical Research

Abel Murillo, MD

Role: PRINCIPAL_INVESTIGATOR

Elite Research Institute

Craig T. Curtis, MD

Role: PRINCIPAL_INVESTIGATOR

Compass Research

Kyle Patrick, D.O.

Role: PRINCIPAL_INVESTIGATOR

Dedicated Phase I

Maxwell Axler, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Network

Ricky S. Mofsen, D.O.

Role: PRINCIPAL_INVESTIGATOR

St. Louis Clinical Trials, LC

Armen Goenjian, MD

Role: PRINCIPAL_INVESTIGATOR

Collaborative Neuroscience Network

Locations

Dedicated Phase I

Phoenix, Arizona, United States

Collaborative Neuroscience Network

Long Beach, California, United States

Elite Research Insitute

Miami, Florida, United States

Compass Research, LLC

Orlando, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

St. Louis Clinical Trials, LC

St Louis, Missouri, United States

Clinical Trial Network

Houston, Texas, United States

Countries

United States

Other Identifiers

LNK754-0902-1AB

Identifier Type: -

Identifier Source: org_study_id