A Safety Study of TTP4000 in Subjects With Alzheimer's Disease
- Registration Number
- NCT01548430
- Lead Sponsor
- vTv Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TTP4000 3.0 mg/kg TTP4000 Administered subcutaneously Placebo Placebo Administered subcutaneously TTP4000 1.0 mg/kg TTP4000 Administered subcutaneously
- Primary Outcome Measures
Name Time Method Number of participant with adverse events Day 0 to Day 84
- Secondary Outcome Measures
Name Time Method Evaluation of participant plasma TTP4000 concentrations Day 0 to Day 84