The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life

Browse trials for

• Dementia 2,172
• Mixed Dementias 24

Keywords

• Dementia
• Mixed Dementia
• Galantamine
• Reminyl ER
• Nimodipine

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 22 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Lead sponsor

Janssen-Cilag Farmaceutica Ltda. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  Galantamine + Nimodipine

  Drug: Galantamine · Drug: Nimodipine

• Experimental
  Galantamine + Placebo

  Drug: Galantamine · Drug: Placebo

Interventions

• DrugGalantamine

  Galantamine 8 mg/day for one month, followed by 4 weeks of galantamine 16 mg/day. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day.

• DrugNimodipine

  Nimodipine 30 mg 3 times a day (tid).

• DrugPlacebo

  Matching placebo three times a day (tid).

Primary outcomes

1. Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24

   The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time. The number one was presented in the center of the computer screen and the patient had to press this number in the response box as quickly as possible. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. The patient's finger was put over button one before the test begun. This test is part of the Computerized Neuropsychological Test Battery (CNTB).

   Time frame: Baseline, Week 8, Week 24

2. Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24

   The Two-choice reaction time test is a computerized attention test in which the numbers one or five were presented in the center of the computer screen in a random order. The patient had to press the correspondent button in the response box as quickly as possible. The patient's right finger was put over the button five and the left finger over button one before the test begun. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24.This test is part of the Computerized Neuropsychological Test Battery (CNTB).

   Time frame: Baseline, Week 8, Week 24

3. Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24

   The face recognition test is a computerized attention test in which ten unfamiliar faces were presented simultaneously on the computer screen for ten seconds to be remembered. After that, a single face was shown and the patient had to press the button one if he/she remembered or, otherwise, button five. It consisted of a random presentation of ten pre-exposed faces and ten new faces as distracters. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Weeks 8 and 24. This test is part of the Computerized Neuropsychological Test Battery.

   Time frame: Baseline, Week 8, Week 24

4. Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24

   The reaction time for word recognition and learning test is a computerized attention test that evaluates the patient's reaction time. This test is similar to the Face Recognition test procedure using Words. The recognition procedure was repeated three times to evaluate a learning effect. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. This test is part of the Computerized Neuropsychological Test Battery (CNTB).

   Time frame: Baseline, Week 8, Week 24

5. The Quality of Life Assessment for Caregivers of Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24

   The Quality of Life assessment scale for caregivers of patients with Alzheimer's disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the caregivers own perceived quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.

   Time frame: Baseline, Week 8, Week 24

6. The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24

   The Quality of Life assessment scale for patients with Alzheimer's disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). Total score ranges from 13 to 52. Higher scores represent a better outcome.

   Time frame: Baseline, Week 8, Week 24

7. 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

   The Quality of Life assessment scale for patients with Alzheimer's disease (QoL-AD), according to the opinion of the caregiver is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the opinion of the caregiver about the patient's quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.

   Time frame: Baseline, Week 8, Week 24

Secondary outcomes

1. The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24

   The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation and praxis using an 11-point Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.

   Time frame: Baseline, Week 8, Week 24

2. The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24

   The Clinical Global Impression (CGI) is a scale to assess treatment response in patients with mental disorders. The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.

   Time frame: Week 4, Week 8, Week 16, Week 24

3. The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24

   The NPI evaluates 12 neuropsychiatric domains: delusions, hallucinations, dysphoria, anxiety, aggression, euphoria, dis-inhibition, irritability/lability, apathy, aberrant motor activity, eating disorders, and night-time behavior disturbances. For present domains, the severity and frequency of the behavior are determined. Frequency is rated 1 (rarely) to 4 (very often) and Severity is scored 1 (mild) to 3 (severe). The product scores vary from 1 (mild and rarely) to 12 (very often and severe). Total scores vary from 0 (no present domain) to 144 (all domains are present, are often and severe).

   Time frame: Baseline, Week 8, Week 24

Baseline characteristics

Publications

• Caramelli P, Laks J, Palmini AL, Nitrini R, Chaves ML, Forlenza OV, Vale Fde A, Barbosa MT, Bottino CM, Machado JC, Charchat-Fichman H, Lawson FL. Effects of galantamine and galantamine combined with nimodipine on cognitive speed and quality of life in mixed dementia: a 24-week, randomized, placebo-controlled exploratory trial (the REMIX study). Arq Neuropsiquiatr. 2014 Jun;72(6):411-7. doi: 10.1590/0004-282x20140055. PubMed 24964105 ↗