Phase 4
Completed N=21
The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life
Source: ClinicalTrials.gov NCT00814658 ↗Enrolled (actual)
21
Serious AEs
9.5%
Results posted
Aug 2013
Primary outcomePrimary: Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24 — 1024.06; 729.18; 466.60; 671.33 milliseconds
Summary
The purpose of this study is to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24 |
1024.06; 729.18; 466.60; 671.33; 467.60; 584.44 | — |
| PRIMARY Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24 |
1919.72; 1096.75; 852.70; 1187.78; 727.60; 1116.25 | — |
| PRIMARY Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24 |
3124.00; 2684.45; 2262.50; 2734.25; 2357.80; 3099.38 | — |
| PRIMARY Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24 |
2022.17; 2978.77; 1966.40; 2379.83; 1722.00; 3038.81 | — |
| PRIMARY The Quality of Life Assessment for Caregivers of Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24 |
34.00; 36.50; 32.00; 33.56; 36.60; 34.88 | — |
| PRIMARY The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24 |
33.56; 32.67; 35.60; 33.11; 36.60; 33.86 | — |
| PRIMARY The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores, Based on the Caregiver's Opinion, at Baseline, Week 8, Week 24 |
28.33; 29.33; 27.80; 29.78; 29.80; 29.13 | — |
| SECONDARY The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24 |
30.40; 28.20; 25.10; 31.03; 25.02; 27.70 | — |
| SECONDARY The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24 |
24.0; 26.92; 20.20; 22.11; 15.00; 19.75 | — |
Eligibility Criteria
Inclusion Criteria
- Patients should fulfill DSM-IV criteria for dementia (APA, 1994)
- Patients should fulfill criteria for AD with cerebrovascular disease according to NINDS-AIREN criteria (Román et al., 1993)
- The severity of dementia should be mild to moderate, as defined by MMSE score between 10 and 26 (inclusive)
- Patients (and their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria
- History of neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease. Patients who have mild extrapyramidal signs, for which no treatment is required, are not excluded from the trial
- History of liver or renal insufficiency
- significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or metabolic disturbances in the past 6 months
- Patients who have previously received M1 agonists or cholinesterase inhibitors (tacrine, donepezil, metrifonate, rivastigmine) for treatment of Alzheimer's disease, no matter if approved or experimental can be included in this trial provided there was at least a washout period of 60 days prior to the screening assessments
- History of drug or alcohol abuse within the last year or prior prolonged history
- History of severe drug allergy or hypersensitivity
- including recorded hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, or bromide
- Subjects who have previously been enrolled in other galantamine trials.
Data sourced from ClinicalTrials.gov (NCT00814658). 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.