NCT01013610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 15, 2011

Status Verified

March 1, 2011

Enrollment Period

1.3 years

First QC Date

November 12, 2009

Last Update Submit

March 14, 2011

Conditions

Mild Alzheimer's Disease

Keywords

Healthy Elderly Volunteers

Outcome Measures

Primary Outcomes (1)

  • Safety assessments to include pharmacokinetics, and adverse events

    24 hours

Study Arms (2)

Multiple Dose

ACTIVE COMPARATOR
Drug: LNK-754

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LNK-754DRUG

Escalating dose

Multiple Dose
PlaceboDRUG

Escalating dose

Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Part A and Part B:
  • 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.
  • Voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures.
  • 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:
  • Part B only:
  • Subjects with Mild Alzheimer's Disease, as defined by DSM-IV.
  • Subjects with a score of ≥ 18-26 on the Mini-Mental State Examination (MMSE).
  • Subjects with a Clinical Dementia Rating (CDR) total score of 0.5 or 1.0 (possible or mild dementia).
  • Subjects with a Rosen-Modified Hachinski Ischemic score of ≤ 4.

You may not qualify if:

  • Part A and Part B:
  • 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.
  • Subjects who have positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
  • 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.
  • Subjects unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Dedicated Phase I

Phoenix, Arizona, 85013, United States

Location

Collaborative Neuroscience Network

Long Beach, California, 90806, United States

Location

Elite Research Insitute

Miami, Florida, 33169, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

St. Louis Clinical Trials, LC

St Louis, Missouri, 63118, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

MeSH Terms

Interventions

LNK-754

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 16, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 15, 2011

Record last verified: 2011-03

Locations

US(7)