A Safety Study of TTP4000 in Subjects With Alzheimer's Disease
A Double-blind, Randomized, Placebo-controlled, Phase 1 Study of 2 Escalating, Single Subcutaneous Doses to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of TTP4000 in Subjects With Alzheimer's Disease With Mild Cognitive Impairment
1 other identifier
interventional
8
1 country
3
Brief Summary
The purpose of the study is to examine the safety, tolerability, immunogenicity and pharmacokinetics of TTP4000 in subjects with Alzheimer's disease with mild cognitive impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2011
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 28, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFebruary 12, 2015
February 1, 2015
1.3 years
February 28, 2012
February 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participant with adverse events
Day 0 to Day 84
Secondary Outcomes (1)
Evaluation of participant plasma TTP4000 concentrations
Day 0 to Day 84
Study Arms (3)
TTP4000 1.0 mg/kg
EXPERIMENTALAdministered subcutaneously
TTP4000 3.0 mg/kg
EXPERIMENTALAdministered subcutaneously
Placebo
PLACEBO COMPARATORAdministered subcutaneously
Interventions
Eligibility Criteria
You may qualify if:
- Males or females ≥ 50 years of age.
- Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
- Weight ≥ 50 kg.
- Alzheimer's disease according to the DSM-IV-TR criteria and a score between 20 and 26 on the Mini Mental State Exam.
- Subject must have a medical history for at least 6 months prior to Screening (confirmed by medical records) of a diagnosis of mild Alzheimer's disease.
You may not qualify if:
- Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including, but not limited to: epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness; DSM-IV-TR criteria for any major psychiatric disorder, including psychosis, major depression, and bipolar disorder.
- Participation and dosing in another clinical trial, involving any marketed or investigational drug, within 30 days before Screening Visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- vTv Therapeuticslead
Study Sites (3)
Unknown Facility
Miami, Florida, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
High Point, North Carolina, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Hernandez, Ph.D.
TransTech Pharma, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2012
First Posted
March 8, 2012
Study Start
October 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 12, 2015
Record last verified: 2015-02