Clinical trial NCT01013610: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mild Alzheimer's Disease
Keywords: Healthy Elderly Volunteers
Lead sponsor: Link Medicine Corporation
Sponsor class: INDUSTRY
First posted: 2009-11-16
Enrollment: 110
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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.

Primary outcomes:
measure: Safety assessments to include pharmacokinetics, and adverse events
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dedicated Phase I
state: Arizona
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Miami
country: United States
facility: Elite Research Insitute
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: St. Louis
country: United States
facility: St. Louis Clinical Trials, LC
state: Missouri
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
Study officials:
affiliation: Atlanta Center for Medical Research
name: Robert Riesenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elite Research Institute
name: Abel Murillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Compass Research
name: Craig T. Curtis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dedicated Phase I
name: Kyle Patrick, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Trial Network
name: Maxwell Axler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis Clinical Trials, LC
name: Ricky S. Mofsen, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: Collaborative Neuroscience Network
name: Armen Goenjian, MD
role: PRINCIPAL_INVESTIGATOR
References: