A Safety Study of TTP4000 in Subjects With Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by TransTech Pharma.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
TransTech Pharma
ClinicalTrials.gov Identifier:
NCT01548430
First received: February 28, 2012
Last updated: August 29, 2012
Last verified: August 2012

February 28, 2012
August 29, 2012
October 2011
September 2012   (final data collection date for primary outcome measure)
Number of participant with adverse events [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01548430 on ClinicalTrials.gov Archive Site
Evaluation of participant plasma TTP4000 concentrations [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Alzheimer's Disease
  • Drug: TTP4000
  • Drug: Placebo
  • Experimental: TTP4000 1.0 mg/kg
    Administered subcutaneously
    Intervention: Drug: TTP4000
  • Experimental: TTP4000 3.0 mg/kg
    Administered subcutaneously
    Intervention: Drug: TTP4000
  • Placebo Comparator: Placebo
    Administered subcutaneously
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
16
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01548430
TTP4000-101
No
TransTech Pharma
TransTech Pharma
Not Provided
Study Director: Robert Hernandez, Ph.D. TransTech Pharma, Inc.
TransTech Pharma
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP