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

NCT00814658 | Completed Phase 4 Results

• 2 other identifiers: CR014938GALDEM4008
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dementia

Keywords

Dementia; Mixed Dementia; Galantamine; Reminyl ER; Nimodipine

Outcome Measures

Primary Outcomes (7)

• 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).

  Baseline, Week 8, Week 24

• 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).

  Baseline, Week 8, Week 24

• 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.

  Baseline, Week 8, Week 24

• 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).

  Baseline, Week 8, Week 24

• 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.

  Baseline, Week 8, Week 24

• 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.

  Baseline, Week 8, Week 24

• 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.

  Baseline, Week 8, Week 24

Secondary Outcomes (3)

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

  Baseline, Week 8, Week 24

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

  Week 4, Week 8, Week 16, Week 24

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

  Baseline, Week 8, Week 24

Study Arms (2)

Galantamine + Nimodipine

EXPERIMENTAL

Drug: Galantamine; Drug: Nimodipine

Galantamine + Placebo

EXPERIMENTAL

Drug: Galantamine; Drug: Placebo

Interventions

Galantamine DRUG

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.

Galantamine + Nimodipine; Galantamine + Placebo

Nimodipine DRUG

Nimodipine 30 mg 3 times a day (tid).

Galantamine + Nimodipine

Placebo DRUG

Matching placebo three times a day (tid).

Galantamine + Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen-Cilag Farmaceutica Ltda.: lead

Related Publications (1)

• 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.

  PMID: 24964105 DERIVED

MeSH Terms

Conditions

Dementia; Mixed Dementias

Interventions

Galantamine; Nimodipine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Nicotinic Acids

Limitations and Caveats

The major limitation of this study was the small sample size. This was probably due to the short enrollment period and to the rigorous inclusion criteria that were adopted.

Results Point of Contact

• Title: Medical Group Manager
• Organization: Jan-Cil Brazil

55 11 3030-2770

Study Officials

• Janssen-Cilag Farmaceutica Ltda. Clinical Trial

  Janssen-Cilag Farmaceutica Ltda.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: December 25, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: August 26, 2013
• Results First Posted: August 26, 2013

Record last verified: 2013-08