Phase 2
Completed N=66
Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease
Source: ClinicalTrials.gov NCT00744978 ↗Enrolled (actual)
66
Serious AEs
1.7%
Results posted
Nov 2011
Primary outcomePrimary: Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6 — 18.07; 18.49 units on scale — p=0.3873
Summary
1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure of cognition in patients with mild to moderate Alzheimer's disease
2. Evaluate the effects of varenicline on clinically relevant measures including attention and executive function, behavior, and clinician rated global change.
3. Evaluate the safety and tolerability of varenicline, relative to placebo, in patients with mild to moderate Alzheimer's disease
4. Evaluate the pharmacokinetics of varenicline in patients with mild to moderate Alzheimer's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6 |
18.07; 18.49 | 0.3873 |
| SECONDARY Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3 |
19.87; 19.31 | 0.2465 |
| SECONDARY Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3 |
19.60; 19.01 | 0.2092 |
| SECONDARY Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6 |
17.86; 18.23 | 0.4339 |
| SECONDARY Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6 |
3.71; 3.70 | 0.9745 |
| SECONDARY Neuropsychiatric Inventory (NPI) Total Score at Week 3 |
2.97; 2.29 | 0.2852 |
| SECONDARY Neuropsychiatric Inventory (NPI) Total Score at Week 6 |
3.82; 2.55 | 0.0468 sig |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1 |
2.65; 2.64 | 0.8811 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3 |
2.65; 2.63 | 0.0830 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6 |
2.64; 2.65 | 0.7226 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1 |
38.52; 40.05 | 0.5588 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3 |
39.43; 43.57 | 0.1173 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6 |
41.67; 42.98 | 0.6251 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1 |
0.94; 0.94 | 0.9109 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3 |
0.96; 0.97 | 0.6632 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6 |
0.95; 0.96 | 0.5450 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1 |
0.83; 0.81 | 0.2799 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3 |
0.82; 0.82 | 0.9675 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6 |
0.83; 0.84 | 0.5008 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1 |
2.79; 2.80 | 0.2245 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3 |
2.79; 2.80 | 0.4974 |
| SECONDARY Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6 |
2.79; 2.79 | 0.8525 |
Eligibility Criteria
Inclusion Criteria
- Males or females, age 55-85
- Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Mini-mental status exam score of 14-26 inclusive
- Rosen-Modified Hachinski Ischemia Score of < or = 4
Exclusion Criteria
- Diagnosis or history of other dementia or neurodegenerative disorders
- Diagnosis or history of clinically significant cerebrovascular or cardiovascular disease
- Subjects with pulmonary disease or evidence of clinically significant pulmonary symptoms
Data sourced from ClinicalTrials.gov (NCT00744978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.