A Safety Study of TTP4000 in Subjects With Alzheimer's Disease
This study has been completed.
Sponsor:
TransTech Pharma, LLC.
Information provided by (Responsible Party):
TransTech Pharma, LLC.
ClinicalTrials.gov Identifier:
NCT01548430
First received: February 28, 2012
Last updated: February 11, 2015
Last verified: February 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: TTP4000 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by TransTech Pharma, LLC.:
Primary Outcome Measures:
- Number of participant with adverse events [ Time Frame: Day 0 to Day 84 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluation of participant plasma TTP4000 concentrations [ Time Frame: Day 0 to Day 84 ] [ Designated as safety issue: No ]
| Enrollment: | 8 |
| Study Start Date: | October 2011 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TTP4000 1.0 mg/kg
Administered subcutaneously
|
Drug: TTP4000 |
|
Experimental: TTP4000 3.0 mg/kg
Administered subcutaneously
|
Drug: TTP4000 |
|
Placebo Comparator: Placebo
Administered subcutaneously
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548430
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548430
Locations
| United States, Florida | |
| Miami, Florida, United States | |
| United States, North Carolina | |
| Durham, North Carolina, United States | |
| High Point, North Carolina, United States | |
Sponsors and Collaborators
TransTech Pharma, LLC.
Investigators
| Study Director: | Robert Hernandez, Ph.D. | TransTech Pharma, Inc. |
More Information
No publications provided
| Responsible Party: | TransTech Pharma, LLC. |
| ClinicalTrials.gov Identifier: | NCT01548430 History of Changes |
| Other Study ID Numbers: | TTP4000-101 |
| Study First Received: | February 28, 2012 |
| Last Updated: | February 11, 2015 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Alzheimer Disease Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Dementia |
Mental Disorders Nervous System Diseases Neurodegenerative Diseases Tauopathies |
ClinicalTrials.gov processed this record on March 02, 2015