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A multicentre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, tolerability and safety of two doses of metrifonate in patients with mild-to-moderate Alzheimer's disease: the MALT study.
Int J Geriatr Psychiatry. 1999 Nov; 14(11):973-82.IJ

Abstract

BACKGROUND

Metrifonate is a long-lasting acetylcholinesterase inhibitor being developed for the symptomatic treatment of Alzheimer's disease (AD).

OBJECTIVES

This study compared the efficacy, tolerability and safety of two doses of metrifonate in patients with mild-to-moderate AD, over a 26-week treatment period.

METHODS

Six hundred and five patients were randomized to placebo (n=208), a 40/50 mg dose (40 or 50 mg by weight; n=200) or a 60/80 mg dose (60 or 80 mg by weight; n=197) metrifonate. Patients randomized to receive metrifonate were administered a once-daily loading dose of 80 or 120 mg based on weight for 2 weeks, followed by the relevant maintenance dose for 24 weeks. Four main clinical domains of AD were assessed: cognition (ADAS-cog and MMSE), psychiatric and behavioural symptoms (ADAS-noncog and NPI), instrumental and basic activities of daily living (DAD) and global functioning (CIBIC-plus, CIBIS-plus and GDS).

RESULTS

ADAS-cog performance was significantly improved in the 60/80 mg and 40/50 mg dose groups, compared with placebo, in the intention-to-treat (ITT) population. In addition, statistically significant treatment differences were demonstrated between the 60/80 mg dose group and placebo on MMSE, ADAS-noncog, the NPI subitems of hallucinations and apathy, DAD, CIBIC-plus, CIBIS-plus and the GDS. The performance of the 40/50 mg dose group was also significantly superior to placebo on the CIBIS-plus and the NPI subitem aberrant motor behaviour.

CONCLUSIONS

Metrifonate significantly improved a wide range of symptoms across all four clinical domains of AD in a dose-dependent manner, and was safe and well tolerated at both doses studied.

Authors+Show Affiliations

Hôpital de la Pitié-Salpêtrière, Paris, France. b.dubois@psl.ap-hop-paris.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10556869

Citation

Dubois, B, et al. "A Multicentre, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Tolerability and Safety of Two Doses of Metrifonate in Patients With Mild-to-moderate Alzheimer's Disease: the MALT Study." International Journal of Geriatric Psychiatry, vol. 14, no. 11, 1999, pp. 973-82.
Dubois B, McKeith I, Orgogozo JM, et al. A multicentre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, tolerability and safety of two doses of metrifonate in patients with mild-to-moderate Alzheimer's disease: the MALT study. Int J Geriatr Psychiatry. 1999;14(11):973-82.
Dubois, B., McKeith, I., Orgogozo, J. M., Collins, O., & Meulien, D. (1999). A multicentre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, tolerability and safety of two doses of metrifonate in patients with mild-to-moderate Alzheimer's disease: the MALT study. International Journal of Geriatric Psychiatry, 14(11), 973-82.
Dubois B, et al. A Multicentre, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Tolerability and Safety of Two Doses of Metrifonate in Patients With Mild-to-moderate Alzheimer's Disease: the MALT Study. Int J Geriatr Psychiatry. 1999;14(11):973-82. PubMed PMID: 10556869.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicentre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, tolerability and safety of two doses of metrifonate in patients with mild-to-moderate Alzheimer's disease: the MALT study. AU - Dubois,B, AU - McKeith,I, AU - Orgogozo,J M, AU - Collins,O, AU - Meulien,D, PY - 1999/11/11/pubmed PY - 1999/11/11/medline PY - 1999/11/11/entrez SP - 973 EP - 82 JF - International journal of geriatric psychiatry JO - Int J Geriatr Psychiatry VL - 14 IS - 11 N2 - BACKGROUND: Metrifonate is a long-lasting acetylcholinesterase inhibitor being developed for the symptomatic treatment of Alzheimer's disease (AD). OBJECTIVES: This study compared the efficacy, tolerability and safety of two doses of metrifonate in patients with mild-to-moderate AD, over a 26-week treatment period. METHODS: Six hundred and five patients were randomized to placebo (n=208), a 40/50 mg dose (40 or 50 mg by weight; n=200) or a 60/80 mg dose (60 or 80 mg by weight; n=197) metrifonate. Patients randomized to receive metrifonate were administered a once-daily loading dose of 80 or 120 mg based on weight for 2 weeks, followed by the relevant maintenance dose for 24 weeks. Four main clinical domains of AD were assessed: cognition (ADAS-cog and MMSE), psychiatric and behavioural symptoms (ADAS-noncog and NPI), instrumental and basic activities of daily living (DAD) and global functioning (CIBIC-plus, CIBIS-plus and GDS). RESULTS: ADAS-cog performance was significantly improved in the 60/80 mg and 40/50 mg dose groups, compared with placebo, in the intention-to-treat (ITT) population. In addition, statistically significant treatment differences were demonstrated between the 60/80 mg dose group and placebo on MMSE, ADAS-noncog, the NPI subitems of hallucinations and apathy, DAD, CIBIC-plus, CIBIS-plus and the GDS. The performance of the 40/50 mg dose group was also significantly superior to placebo on the CIBIS-plus and the NPI subitem aberrant motor behaviour. CONCLUSIONS: Metrifonate significantly improved a wide range of symptoms across all four clinical domains of AD in a dose-dependent manner, and was safe and well tolerated at both doses studied. SN - 0885-6230 UR - https://www.unboundmedicine.com/medline/citation/10556869/A_multicentre_randomized_double_blind_placebo_controlled_study_to_evaluate_the_efficacy_tolerability_and_safety_of_two_doses_of_metrifonate_in_patients_with_mild_to_moderate_Alzheimer's_disease:_the_MALT_study_ L2 - https://medlineplus.gov/alzheimersdisease.html DB - PRIME DP - Unbound Medicine ER -