Alzheimer Disease
Conditions
Brief summary
Objectives: The objective of this study will be to determine the safety, tolerability, drug blood levels, and efficacy of each of three doses of NS 2330 (Tesofensine) given once daily compared with placebo in patients with mild to moderate Dementia of the Alzheimer's Type.
Interventions
DRUGNS 2330 (Tesofensine)
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients may be included in this study if they meet all of the following criteria: 1. Male, and female without child bearing potential between 40 and 85 years of age, inclusive. Women who have been postmenopausal for less than 2 years must have a negative pregnancy test at screening. 2. Diagnosis of probable mild to moderate Dementia of the Alzheimer's Type as defined by National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS ADRDA) guidelines.9 3. Mini-Mental State Examination (MMSE) score of 10-24 and Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) score greater than 12 at screening. 4. Modified Hachinski Scale10 score no greater than 4. 5. Central nervous system imaging (CT or MRI scan of brain) compatible with Dementia of the Alzheimer's Type within the past year (also see
Exclusion criteria
). 6. Exhibits reliability and physiologic capability sufficient to comply with all protocol procedures. Patient must be familiar with and fluent in English (i.e., sufficient to complete all study assessments from the language perspective). 7. Patients and/or a legal representative and their caregivers must have given informed consent. The legal representative and caregiver may be the same person. 8. Patient must have a reliable caregiver that is in frequent or daily contact with the patient, who will accompany the patient to the office and who will monitor the administration of prescribed medications. The caregiver will be able to communicate in English and be willing to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) | week 0, 4, 9, 14 and 20 |
Secondary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Cooperative Study-Activities of Daily Living | weeks 0, 4, and 14 |
| Neuropsychiatric Inventory | weeks 0, 4, and 14 |
| Mini-Mental State Examination | weeks 0 and 14 |
| ADAS-Cog Extension | weeks 0, 4, 9, 14 and 20 |
| ADAS-Cog total score including Extension | weeks 0, 4, and 14 |
| types and frequencies of adverse events | 20 weeks |
| Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change | weeks 0 and 14 |
| changes from baseline in vital signs | 20 weeks |
| changes from baseline in laboratory measurements | 20 weeks |
| changes from baseline in ECG readings | 20 weeks |
| comparison of study groups for drug plasma concentrations | weeks 0, 4, 9, 14 and 20 |
| population PK parameters | Weeks 0, 4, 9, 14 and 20 |
| proportion of patients discontinued from the trial because of adverse events | 20 weeks |
Countries
Canada, United States
Outcome results
None listed