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

Mild Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013610
• Other study ID #: LNK754-0902-1AB
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2009
• Last updated: March 14, 2011
• Start date: November 2009
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Link Medicine Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Alzheimer Disease
• Mild Alzheimer's Disease

Intervention

Drug:
• LNK-754
Escalating dose
• Placebo
Escalating dose

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Clinical Trial Network	Houston	Texas
United States	Collaborative Neuroscience Network	Long Beach	California
United States	Elite Research Insitute	Miami	Florida
United States	Compass Research, LLC	Orlando	Florida
United States	Dedicated Phase I	Phoenix	Arizona
United States	St. Louis Clinical Trials, LC	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Link Medicine Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessments to include pharmacokinetics, and adverse events		24 hours	No