An Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type

What Was Tested

In this phase 2 trial, researchers set out to test Tesofensine (non-peptide) for dementia, alzheimer's & cognitive decline.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 430 actual participants took part.

It was open to people of any sex aged from 40 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Modified Hachinski Scale10 score no greater than 4. Central nervous system imaging (CT or MRI scan of brain) compatible with Dementia of the Alzheimer's Type within the past year (also see.

The full record lists 5 inclusion and 31 exclusion criteria; among the exclusions: patients and/or a legal representative and their caregivers must have given informed consent. the legal representative and caregiver may be the same person; secondary disorders inducing dementia such as neurosyphilis, craniocerebral trauma (ct/mri), hyperthyroidism, or folic acid deficiency; history of malignancy within 3 years, except for basal cell carcinoma.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Tesofensine (non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the dementia, alzheimer's & cognitive decline participants stayed in one arm throughout.

Blinding on both sides kept the dementia, alzheimer's & cognitive decline participants and researchers unaware of who received Tesofensine (non-peptide).

It started in 2003-02 with completion listed for 2005-03.

It ran at 87 sites in United States (80) and Canada (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) (time frame: week 0, 4, 9, 14 and 20).

It also tracked 13 secondary outcomes, for example Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change, Alzheimer's Disease Cooperative Study-Activities of Daily Living, Neuropsychiatric Inventory, Mini-Mental State Examination, ADAS-Cog Extension and ADAS-Cog total score including Extension.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesofensine (non-peptide) in 430 people with dementia, alzheimer's & cognitive decline.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tesofensine (non-peptide) compound page, Dementia, Alzheimer's & cognitive decline research.