NCT01548430
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- TTP4000
- Conditions
- Alzheimer's Disease
- Sponsor
- vTv Therapeutics
- Enrollment
- 8
- Primary Endpoint
- Number of participant with adverse events
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
TTP4000 1.0 mg/kg
Administered subcutaneously
Intervention: TTP4000
TTP4000 3.0 mg/kg
Administered subcutaneously
Intervention: TTP4000
Placebo
Administered subcutaneously
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participant with adverse events
Time Frame: Day 0 to Day 84
Secondary Outcomes
- Evaluation of participant plasma TTP4000 concentrations(Day 0 to Day 84)
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